A Phase 1/2 interventional study of Cyclophosphamide and Doxorubicin Hydrochloride in AIDS-Related Plasmablastic Lymphoma, AIDS-Related Primary Effusion Lymphoma and Ann Arbor Stage I Diffuse Large B-Cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy alone in treating patients with human immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving vorinostat together with combination chemotherapy and rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Determine the recommended phase II dose (RPTD) of vorinostat that may be used in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride and rituximab (R-DA-EPOCH) (in high-risk disease) in participants with human immunodeficiency virus (HIV)-associated aggressive cluster of differentiation (CD)20 positive non-Hodgkin lymphoma (NHL). (Phase I) II. Determine the overall toxicity rates of R-DA-EPOCH (in high-risk disease) with and without vorinostat. (Phase II) III. Determine the efficacy of the combinations of R-DA-EPOCH (in high-risk disease) with and without vorinostat in HIV-associated aggressive CD20 positive NHL using complete response (CR) rates as study endpoints. (Phase II)
SECONDARY OBJECTIVES:
I. Determine 1-year event-free survival (EFS) and 1 year overall survival (OS). II. Assess the effect of vorinostat and chemotherapy on latent HIV in memory T cells.
III. Assess the effect of vorinostat and/or chemotherapy on HIV, Epstein-Barr virus (EBV), and human herpes virus 8 (HHV-8) viral loads on banked specimens.
IV. Assess the effect of vorinostat and/or chemotherapy on T-cell subsets (CD4 and CD8) and plasma immunoglobulin levels.
V. Assess the effect of concurrent vorinostat and rituximab on plasma steady-state concentrations of etoposide, doxorubicin (doxorubicin hydrochloride), and vincristine (vincristine sulfate) (on Phase I only).
VI. Perform wide human gene expression profiling and methylation studies in tumors banked at baseline.
VII. Evaluate EBV and HHV-8 gene expression patterns in positive tumors banked at baseline.
OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II study.
PHASE I: Patients receive vorinostat orally (PO) once daily (QD) on days 1-5; rituximab intravenously (IV) on day 1; etoposide IV over 24 hours, doxorubicin hydrochloride IV over 24 hours, and vincristine sulfate IV over 24 hours on days 1-4; prednisone PO daily on days 1-5; and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 treatment arms.
ARM A (VR-DA-EPOCH): Patients receive vorinostat, rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Phase I.
ARM B (DA-R-EPOCH): Patients receive rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Arm A.
In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 107 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with or cytologically documented diffuse large B-cell lymphoma (DLBCL) must meet at least 1 of the following risk criteria:
Double hit variant, defined as having v-myc avian myelocytomatosis viral oncogene homolog (MYC) gene rearrangement in the presence of B-cell chronic lymphocytic leukemia (CLL)/lymphoma (BCL) 2 or BCL6 gene rearrangement
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive vorinostat PO QD on days 1-5; rituximab IV on day 1; etoposide IV over 24 hours, doxorubicin hydrochloride IV over 24 hours, and vincristine sulfate IV over 24 hours on days 1-4; prednisone PO daily on days 1-5; and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Cyclophosphamide · Drug: Doxorubicin Hydrochloride · Drug: Etoposide · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Prednisone · Biological: Rituximab · Drug: Vincristine Sulfate · Drug: Vorinostat
Patients receive rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Cyclophosphamide · Drug: Doxorubicin Hydrochloride · Drug: Etoposide · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Prednisone · Biological: Rituximab · Drug: Vincristine Sulfate
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Given IV
Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex
Given IV
Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16
Correlative studies
Correlative studies
Given PO
Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima
Given IV
Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
Given PO
Also known as: L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).
Time frame: Up to 6 months
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.
Time frame: Up to 5 years
Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Time frame: 21 days
Change in CD8 Cell Counts (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts.
Time frame: Baseline up to 12 months
Changes in Absolute CD4 Cell Counts (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.
Time frame: Baseline up to 12 months
Changes in Epstein-Barr Virus (EBV) Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.
Time frame: Baseline up to 12 months
Changes in Human Herpes Virus (HHV)-8 Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.
Time frame: Baseline up to 12 months
Changes in Human Immunodeficiency Virus (HIV) Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Time frame: Baseline up to 12 months
Event-free Survival (EFS) (Phase II)
The percentage of participants surviving without events (relapse or death) one year after starting treatment.
Time frame: 1 year
Overall Survival (OS) (Phase II)
The percentage of participants surviving one year after starting treatment.
Time frame: 1 year
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Time frame: Baseline up to 12 months
Pharmacokinetic Clearance (Phase I)
Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.
Time frame: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion
Tumor Response (Phase I)
The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease
Time frame: Up to 2 years post treatment
| Milestone | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| Started | 3 | 0 | 0 | 0 | 0 |
| Completed | 3 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| Started | 0 | 7 | 0 | 0 | 0 |
| Completed | 0 | 6 | 0 | 0 | 0 |
| Not completed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Ineligible | 0 | 1 | 0 | 0 | 0 |
| Milestone | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| Started | 4 | 0 | 0 | 0 | 0 |
| Completed | 3 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Ineligible | 1 | 0 | 0 | 0 | 0 |
| Milestone | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| Started | 0 | 0 | 2 | 0 | 0 |
| Completed | 0 | 0 | 1 | 0 | 0 |
| Not completed | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Noncompliant (cycle 1 not complete) | 0 | 0 | 1 | 0 | 0 |
| Milestone | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 45 | 46 |
| Completed | 0 | 0 | 0 | 33 | 36 |
| Not completed | 0 | 0 | 0 | 12 | 10 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 5 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Ineligible | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Disease progression/relapse on treatment | 0 | 0 | 0 | 5 | 3 |
Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).
| percentage of participants | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|
| Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) | 67.5 (50.9 to 81.4) | 76.2 (60.6 to 88.0) |
The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.
| percentage of participants | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|
| Death | 28.9 | 20.0 |
| Life-threatening | 37.8 | 28.9 |
| Severe | 20.0 | 31.1 |
| Moderate | 8.9 | 17.8 |
| Mild | 2.2 | 0 |
Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
| Mg per day of Vorinostat | Phase I: VR-DA-EPOCH |
|---|---|
| Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I) | 300 |
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts.
| cells/mm^3 | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 |
|---|---|---|---|
| End of cycle 2 | 35.5 (-348.5 to 356.5) | -115 (-162 to 75) | -172 (-172 to -172) |
| Treatment discontinuation | -164.5 (-962.5 to 198.5) | 211 (18 to 359) | -81 (-81 to -81) |
| 6-month follow-up | -56 (-177 to 443) | 275 (-152 to 728) | -16 (-16 to -16) |
| 12-month follow-up | 604 (604 to 604) | 154 (-97 to 692) | 128 (128 to 128) |
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.
| cell/mm^3 | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 |
|---|---|---|---|
| End of cycle 2 | 92 (9 to 143) | -9 (-41 to 49) | -218 (-218 to -218) |
| Treatment discontinuation | -39 (-53 to 56) | -29 (-32 to 41) | -190 (-190 to -190) |
| 6-month follow-up | 76 (75 to 181) | 31 (-9 to 45) | -175 (-175 to -175) |
| 12-month follow-up | 169 (169 to 169) | 31 (-16 to 104) | -84 (-84 to -84) |
Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.
| IU/mL | Phase II, VR-DA-EPOCH | Phase II, DA-R-EPOCH | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 |
|---|---|---|---|---|---|
| End of Cycle 2 | -0.61 (-104.1 to 0) | 0 (-0.61 to 0) | 0 (0 to 0) | -2436.1 (-2436.1 to -2436.1) | — |
| At treatment discontinuation | -2.9 (-449.6 to -0.14) | -0.28 (-1.9 to 0) | 0 (0 to 0) | -1.92 (-1.92 to -1.92) | — |
| 6-month follow-up | -1.55 (-2.98 to 0) | 0 (-4.87 to 4.07) | 0 (0 to 0) | -1.92 (-1.92 to -1.92) | — |
| 12-month follow-up | -0.56 (-228.2 to -0.07) | -2.7 (-4.75 to 0) | 0 (0 to 0) | -1.15 (-1.15 to -1.15) | — |
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.
| copies per 100uL | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|
| At treatment discontinuation | — | 0 (0 to 0) |
| 6-month follow-up | — | 0 (0 to 0) |
| 12-month follow-up | 0 (0 to 0) | 0 (0 to 0) |
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
| median change in copies per mL | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|
| End of Cycle 2 | -20 (-22607 to 0) | -25 (-3308 to 0) |
| At treatment discontinuation | -87 (-28176 to 0) | -22.5 (-1962 to 4.5) |
| 6-month follow-up | -20 (-24703 to 0) | -18 (-3258 to 0) |
| 12-month follow-up | 0 (-22656 to 20) | -20 (-3361 to 0) |
The percentage of participants surviving without events (relapse or death) one year after starting treatment.
| percentage of participants | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|
| Event-free Survival (EFS) (Phase II) | 75.6 (63.0 to 88.1) | 82.2 (71.1 to 93.4) |
The percentage of participants surviving one year after starting treatment.
| percentage of participants | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|
| Overall Survival (OS) (Phase II) | 77.6 (65.3 to 89.8) | 86.7 (76.7 to 96.6) |
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
| copies per milliliter | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 |
|---|---|---|---|
| End of cycle 2 | -14518 (-54352 to 0) | -12.5 (-66 to 0) | 28 (28 to 28) |
| Treatment discontinuation | -4517 (-55116 to 0) | 0 (-88 to 49) | 0 (0 to 0) |
| 6-month follow-up | -55116 (-282977 to 0) | 0 (-88 to 0) | 0 (0 to 0) |
| 12-month follow-up | 0 (0 to 0) | 0 (-88 to 0) | 0 (0 to 0) |
Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.
| Liter/hour | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 |
|---|---|---|---|
| Doxorubicin | 78.6 ± 48.0 | 76.0 ± 47.9 | — |
| Etoposide | 3.0 ± 1.6 | 2.4 ± 0.7 | — |
| Vincristine | 22.4 ± 10.2 | 16.8 ± 8.9 | — |
The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease
| percentage of participants | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: Arm C (VR-CHOP) Dose Level 1 |
|---|---|---|---|
| Complete response | 83.3 (35.9 to 99.6) | 83.3 (35.9 to 99.6) | 100 (2.5 to 100) |
| Partial Response | 16.7 (0.4 to 64.1) | 16.7 (0.4 to 64.1) | 0 (0 to 97.5) |
Collected over Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I: VR-DA-EPOCH, Dose Level 1 | 2/7 (28.6%) | 5/7 (71.4%) | 7/7 (100%) |
| Phase I: VR-DA-EPOCH, Dose Level 2 | 1/7 (14.3%) | 3/7 (42.9%) | 6/7 (85.7%) |
| Phase I: VR-CHOP, Dose Level 1 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Phase II: VR-DA-EPOCH | 13/45 (28.9%) | 25/45 (55.6%) | 43/45 (95.6%) |
| Phase II: DA-R-EPOCH | 9/46 (19.6%) | 21/46 (45.7%) | 43/46 (93.5%) |
| Event | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| Neutrophil Count DecreasedInvestigations | 5/7 | 2/7 | 0/2 | 12/45 | 2/46 |
| White Blood Cell DecreasedInvestigations | 5/7 | 0/7 | 0/2 | 5/45 | 1/46 |
| Platelet Count DecreasedInvestigations | 0/7 | 3/7 | 0/2 | 11/45 | 0/46 |
| Abdominal PainGastrointestinal disorders | 2/7 | 0/7 | 0/2 | 2/45 | 1/46 |
| ColitisGastrointestinal disorders | 2/7 | 0/7 | 0/2 | 0/45 | 1/46 |
| DiarrheaGastrointestinal disorders | 2/7 | 0/7 | 0/2 | 0/45 | 0/46 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/7 | 0/7 | 0/2 | 10/45 | 8/46 |
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) - Other, SpecifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/7 | 0/7 | 0/2 | 7/45 | 4/46 |
| AnemiaBlood and lymphatic system disorders | 1/7 | 0/7 | 0/2 | 1/45 | 2/46 |
| Cardiac ArrestCardiac disorders | 0/7 | 1/7 | 0/2 | 3/45 | 2/46 |
| Event | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II: VR-DA-EPOCH | Phase II: DA-R-EPOCH |
|---|---|---|---|---|---|
| FatigueGeneral disorders | 2/7 | 2/7 | 2/2 | 18/45 | 13/46 |
| NauseaGastrointestinal disorders | 6/7 | 3/7 | 1/2 | 20/45 | 22/46 |
| AnemiaBlood and lymphatic system disorders | 2/7 | 4/7 | 1/2 | 27/45 | 23/46 |
| Platelet Count DecreasedInvestigations | 4/7 | 3/7 | 1/2 | 27/45 | 19/46 |
| Neutrophil Count DecreasedInvestigations | 4/7 | 2/7 | 0/2 | 24/45 | 19/46 |
| White Blood Cell DecreasedInvestigations | 3/7 | 2/7 | 0/2 | 25/45 | 21/46 |
| HyperglycemiaMetabolism and nutrition disorders | 0/7 | 2/7 | 0/2 | 23/45 | 16/46 |
| HypokalemiaMetabolism and nutrition disorders | 2/7 | 1/7 | 0/2 | 23/45 | 15/46 |
| VomitingGastrointestinal disorders | 2/7 | 1/7 | 1/2 | 10/45 | 9/46 |
| Lymphocyte Count DecreasedInvestigations | 1/7 | 3/7 | 1/2 | 20/45 | 19/46 |
Eligible participants completing at least one cycle of treatment; 3 ineligible participants and 1 participant not completing one cycle of Phase I treatment were not included.
| Age, Continuous(years) | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II, V+DA-EPOCH | Phase II, DA-R-EPOCH | Total |
|---|---|---|---|---|---|---|
| Mean | 45.7 ± 12.4 | 50.4 ± 10.1 | 59.5 ± 0 | 49.2 ± 10.1 | 45 ± 9.2 | 47.2 ± 9.8 |
| Sex: Female, Male(Participants) | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II, V+DA-EPOCH | Phase II, DA-R-EPOCH | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 1 | 0 | 6 | 0 | 7 |
| Male | 6 | 5 | 1 | 39 | 45 | 96 |
| Ethnicity (NIH/OMB)(Participants) | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II, V+DA-EPOCH | Phase II, DA-R-EPOCH | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 14 | 13 | 29 |
| Not Hispanic or Latino | 5 | 5 | 1 | 29 | 30 | 70 |
| Unknown or Not Reported | 0 | 0 | 0 | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II, V+DA-EPOCH | Phase II, DA-R-EPOCH | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 12 | 8 | 22 |
| White | 4 | 6 | 1 | 23 | 31 | 65 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 8 | 4 | 12 |
| Region of Enrollment(Participants) | Phase I: VR-DA-EPOCH, Dose Level 1 | Phase I: VR-DA-EPOCH, Dose Level 2 | Phase I: VR-CHOP, Dose Level 1 | Phase II, V+DA-EPOCH | Phase II, DA-R-EPOCH | Total |
|---|---|---|---|---|---|---|
| United States | 6 | 6 | 1 | 45 | 45 | 103 |
Ran from Oct 2010 to primary completion in Nov 2016, 73 months.
Results were first posted in Jun 2018, 1 year 7 months after primary completion.
Of 35 non-industry phase 1/2 interventional studies under HIV Infections, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's 73 months is above that.
Counting every sponsor, half of 42 studies reached it within 47 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Rituximab
National Cancer Institute (NCI) →