A Phase 2 interventional study of cyclophosphamide and doxorubicin hydrochloride in AIDS-related Diffuse Large Cell Lymphoma, AIDS-related Diffuse Mixed Cell Lymphoma and AIDS-related Diffuse Small Cleaved Cell Lymphoma, sponsored by AIDS Malignancy Consortium. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by AIDS Malignancy Consortium · Phase 2, Interventional, and Treatment
This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral chemotherapy works in treating patients with previously untreated stage III-IV human immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells
PRIMARY OBJECTIVES:
I. To compare the efficacy of standard cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) and an oral chemotherapy regimen for acquired immune deficiency syndrome (AIDS)-related (AR)-non-Hodgkin lymphoma (NHL) in sub-Saharan Africa with respect to overall survival (OS).
SECONDARY OBJECTIVES:
I. To compare the objectives response rate (ORR) of persons randomized to CHOP and oral chemotherapy.
II. To compare the progression free survival (PFS) of persons randomized to CHOP and oral chemotherapy.
III. To compare the safety and tolerance of persons randomized to CHOP and oral chemotherapy.
TERTIARY OBJECTIVES:
I. To describe the rates of completion of therapy of persons randomized to CHOP and oral chemotherapy.
II. To describe adherence to chemotherapy of persons randomized to CHOP and oral chemotherapy.
III. To describe adherence to antiretroviral therapy of persons randomized to CHOP and oral chemotherapy.
IV. To describe the effects of therapy on HIV control, as measured by cluster of differentiation (CD)4 counts and HIV viral load.
V. To investigate correlates of survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive CHOP chemotherapy comprising cyclophosphamide intravenously (IV) on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive lomustine PO once daily (QD) on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.
25 studies on the registry are indexed under Lymphoma, AIDS-Related; 2 are open to participants now.
This study's enrollment of 7 is below the median of 18 across 13 interventional studies indexed under Lymphoma, AIDS-Related.
Browse Lymphoma, AIDS-Related studies →AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 9 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) 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.
-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 ribonucleic acid (RNA) viral load > 1,000 copies/mL
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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 protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: vincristine sulfate · Drug: prednisone · Other: laboratory biomarker analysis
Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Drug: lomustine · Drug: etoposide · Drug: cyclophosphamide · Drug: procarbazine hydrochloride · Other: laboratory biomarker analysis
Given IV
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given IV
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Given IV
Also known as: leurocristine sulfate, VCR, Vincasar PFS
Given PO
Also known as: DeCortin, Deltra
Given PO
Also known as: Belustine, CCNU, CeeNU
Given PO
Also known as: EPEG, VP-16, VP-16-213
Given PO
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given PO
Also known as: Ibenzmethyzin, Matulane, MIH, Natulan, PCB
Correlative studies
Overall Survival
Proportion of participants who survived 2 years
Time frame: Up to 24 months
Overall Response Rate
Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is \>=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease.
Time frame: Up to 24 months
Progression-free Survival
Proportion of participants who survived without disease progression at 2 years
Time frame: Up to 24 months
Participants Who Experienced an Adverse Event
Number of participants who experienced an adverse event
Time frame: Up to 24 months
Number of Patients Who Complete Treatment
Number of patients who complete chemotherapy treatment.
Time frame: Up to 18 weeks
Proportion of Patients Who Are Adherent to Antiretroviral Therapy
Number of patients who did not miss any of their doses of antiretroviral therapy
Time frame: Up to 24 months
Proportion of Patients Who Are Adherent to Chemotherapy
Patients who did not miss any doses of chemotherapy
Time frame: Up to 18 weeks
Change in Absolute CD4 Count From Baseline to Post-treatment
Change in absolute CD4 count from baseline to post-treatment (visit 6)
Time frame: From baseline to 18 weeks
| Milestone | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Started | 4 | 3 |
| Completed | 1 | 0 |
| Not completed | 3 | 3 |
| Withdrew: Death | 3 | 3 |
Proportion of participants who survived 2 years
| Proportion of participants | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Overall Survival | 0 (0 to 0) | 0 (0 to 0) |
Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is \>=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease.
| Participants | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Overall Response Rate | 3 | 1 |
Proportion of participants who survived without disease progression at 2 years
| proportion | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Progression-free Survival | 0 (0 to 0) | 0 (0 to 0) |
Number of participants who experienced an adverse event
| Participants | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Participants Who Experienced an Adverse Event | 4 | 3 |
Number of patients who complete chemotherapy treatment.
| Participants | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Number of Patients Who Complete Treatment | 3 | 1 |
Number of patients who did not miss any of their doses of antiretroviral therapy
| Participants | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Proportion of Patients Who Are Adherent to Antiretroviral Therapy | 3 | 3 |
Patients who did not miss any doses of chemotherapy
| Participants | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Proportion of Patients Who Are Adherent to Chemotherapy | 4 | 3 |
Change in absolute CD4 count from baseline to post-treatment (visit 6)
| cells per mm^3 | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Change in Absolute CD4 Count From Baseline to Post-treatment | -41.3 ± 136.5 | 203.3 ± 153.1 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (CHOP) | 3/4 (75%) | 4/4 (100%) | 4/4 (100%) |
| Arm II (Oral Chemotherapy) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| Event | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Neoplasms, otherNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/4 | 2/3 |
| HeadacheNervous system disorders | 2/4 | 0/3 |
| FeverGeneral disorders | 0/4 | 1/3 |
| Death cause unknownGeneral disorders | 0/4 | 1/3 |
| FatigueGeneral disorders | 1/4 | 0/3 |
| Encephalitis infectionInfections and infestations | 1/4 | 0/3 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/4 | 0/3 |
| Event | Arm I (CHOP) | Arm II (Oral Chemotherapy) |
|---|---|---|
| Alkaline phosphataseInvestigations | 1/4 | 2/3 |
| HyponatremiaMetabolism and nutrition disorders | 1/4 | 2/3 |
| Neutrophil count decreasedInvestigations | 2/4 | 1/3 |
| AnemiaBlood and lymphatic system disorders | 1/4 | 1/3 |
| Blood and lymphatic system disorders, otherBlood and lymphatic system disorders | 1/4 | 1/3 |
| TinnitusEye disorders | 0/4 | 1/3 |
| ConstipationGastrointestinal disorders | 0/4 | 1/3 |
| VomitingGastrointestinal disorders | 1/4 | 1/3 |
| Lymphocyte count decreasedInvestigations | 0/4 | 1/3 |
| White blood cell decreasedInvestigations | 1/4 | 1/3 |
| Age, Continuous(years) | Arm I (CHOP) | Arm II (Oral Chemotherapy) | Total |
|---|---|---|---|
| Median | 52.5 (43.0 to 55.0) | 46.0 (39.0 to 47.0) | 47.0 (39.0 to 55.0) |
| Sex: Female, Male(Participants) | Arm I (CHOP) | Arm II (Oral Chemotherapy) | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (CHOP) | Arm II (Oral Chemotherapy) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 3 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm I (CHOP) | Arm II (Oral Chemotherapy) | Total |
|---|---|---|---|
| Zimbabwe | 1 | 0 | 1 |
| Kenya | 1 | 2 | 3 |
| Malawi | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2016 to primary completion in Apr 2021, 54 months.
Results were first posted in Oct 2022, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Lomustine · Etoposide · Procarbazine
AIDS Malignancy Consortium