A Phase 3 interventional study of Autologous transplantation using rituxan/BEAM and Autologous transplantation using Bexxar/BEAM in Lymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic and Lymphoma, Non-Hodgkin, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 36 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 3, Interventional, and Treatment
Among 398 studies in Lymphoma, B-Cell with a site in United States — 91 open to participants now, 159 under way, 12 of them phase 3. Lymphoma, B-Cell · United States.
Among the 398 studies in Lymphoma, B-Cell with a site in United States, this one is the 39th largest by enrollment of the 380 interventional ones that give a count, is one of 9 that started in 2005, is one of 22 in phase 3, and was the 30th registered.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
Browse Lymphoma, B-Cell studies →91 of the 398 studies in Lymphoma, B-Cell with a site in United States are open now. Recruiting first, the newest first:
Umoja Biopharma · Sites in United States
Ages 18+
Nurix Therapeutics, Inc. · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 18+
Paolo Caimi, MD · Sites in United States
Ages 18+
University of Michigan Rogel Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
398 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 236 · Phase 2 188 · Phase 3 23 · Phase 4 1
First in 1991; this study’s year is marked. 9 started in 2005.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 224 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Median enrollment 37 across the 380 interventional studies, 150 across the 17 observational. Of the 216 that completed or were terminated, 110 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
176 of 398 have an industry lead sponsor. The 10 most frequent:
National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.
National Heart, Lung, and Blood Institute (NHLBI) has 2 studies filed under Lymphoma, B-Cell — fewer than ten, so there is no comparison to draw.
52 of the studies in Lymphoma, B-Cell with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT04759586Phase 3National Cancer Institute (NCI)Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma | 2027-06-30 |
| NCT05254743Phase 3Loxo Oncology, Inc.A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | 2027-10 |
| NCT06047080Phase 3Hoffmann-La RocheAn Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma | 2027-10-01 |
| NCT04662255Phase 3Loxo Oncology, Inc.Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) | 2027-11 |
Among the 398 studies in Lymphoma, B-Cell with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is designed as a Phase III, multicenter trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM.
BACKGROUND:
Bexxar (Tositumomab and Iodine I 131 Tositumomab) is a radioimmunoconjugate with demonstrated anti-lymphoma effects. This drug is indicated for the treatment of patients with CD20 positive, relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin's lymphoma. Bexxar has been used in several Phase I and II transplant trials either alone or in combination with high-dose chemotherapy for the treatment of relapsed non-Hodgkin's lymphoma. The Phase I and II trials combining Bexxar with BEAM and autologous hematopoietic stem cell transplantation demonstrated promising early results with 80% event-free survival in relapsed chemosensitive diffuse large B-cell non-Hodgkin's lymphoma patients. The administration of Rituxan to the mobilization and conditioning regimen is now the standard of care at most transplant centers. Therefore, the primary endpoint of this study will be to compare progression-free survival after autologous hematopoietic stem cell transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using Rituxan/BEAM versus Bexxar/BEAM for pre-transplant conditioning.
DESIGN NARRATIVE:
All patients will receive induction or salvage chemotherapy as indicated by their clinical circumstance to achieve at least a partial response (as defined in the protocol). There must be 20% or less bone marrow involvement after their most recent salvage therapy.
Mobilization therapy may be employed per institutional guidelines, but all patients must receive one dose of rituxan (375 mg/m\^2) at least within 4 weeks of actual stem cell apheresis. Patients must have an adequate autograft (target of at least 2.0 X 10\^6 CD34+ cells/kg; minimum of more than 1.5 X 106 CD34+ cells/kg) to be eligible for the protocol. Eligible patients will be randomized to receive either: 1) Rituxan plus BEAM, with Rituxan 375 mg/m\^2 IV Days -19 and -12, Carmustine (BCNU) 300 mg/m\^2 Day -6, Etoposide 100 mg/m\^2 Days -5 to -2, Cytarabine 100 mg/m\^2 Days -5 to -2, and Melphalan 140 mg/m\^2 Day -1 followed by ASCT; or, 2) Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive BCNU 300 mg/m\^2 Day -6, Etoposide 100 mg/m\^2 Days -5 to -2, Cytarabine 100 mg/m\^2 Days -5 to -2, and Melphalan 140 mg/m\^2 Day -1 followed by ASCT.
Patients will be followed for 2 years post-transplant. Survival data, hematopoiesis data, incidence of infection, mucositis assessment data, immune reconstitution data, and toxicity data will be recorded and reported periodically to the BMT CTN Data Coordinating Center (DCC).
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.
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 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.
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.
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.
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.
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.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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).
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 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.
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.
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autologous transplantation using rituxan/BEAM
Drug: Autologous transplantation using rituxan/BEAM
Autologous transplantation using Bexxar/BEAM
Drug: Autologous transplantation using Bexxar/BEAM
Drug page: Rituximab
Rituxan 375 mg/m2 (Day -19 and Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
Also known as: Rituximab
Bexxar dosimetric dose 5 mCi (Day -19); Bexxar therapy dose 75 cGy TBD (Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
Also known as: Tositumomab and Iodine I 131 Tositumomab Bexxar
Progression-free Survival (PFS)
Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.
Time frame: 1 and 2 years
Overall Survival
The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation
Time frame: 1 and 2 years
Incidence of Relapse/Progression
The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.
Time frame: 1 and 2 years
Complete Response (CR) and Partial Response (PR) Proportion
Time frame: Day 100 and 2 years
Platelet Recovery to 20,000 Cells/μL
Time frame: 100 and 180 days
Hematologic Function
Hematologic function will be defined as ANC \> 1,500 neutrophils/μL, hemoglobin \> 10 g/dL without transfusion support, and platelet count \> 100,000/μL without transfusion support.
Time frame: 100 days, 1 year
Incidence of Infection
Time frame: 1 year
Mucositis Severity
Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.
Time frame: Day 21
Immune Reconstitution
Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.
Time frame: 1 year
Immune Reconstitution of Quantitative Immunoglobulins
Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.
Time frame: 1 year
Treatment-related Mortality (TRM)
TRM is defined as death occurring in a patient from causes other than relapse or progression
Time frame: 1 and 2 years
Neutrophil Recovery
Time to neutrophil recovery will be the first of two consecutive days of \> 500 neutrophils/μL following the expected nadir.
Time frame: Day 28 and Day 60
| Milestone | B-BEAM | R-BEAM |
|---|---|---|
| Started | 111 | 113 |
| Completed | 103 | 107 |
| Not completed | 8 | 6 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Progressive disease | 6 | 2 |
| Withdrew: Ineligible pathology | 1 | 1 |
Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| 1 year | 53.2 (43.5 to 61.9) | 56.6 (46.8 to 65.2) |
| 2 years | 48.6 (39.0 to 57.5) | 49.0 (39.3 to 58.0) |
The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| 1 year | 68.5 (58.9 to 76.2) | 73.7 (64.4 to 80.9) |
| 2 years | 60.1 (50.3 to 68.6) | 66.3 (56.6 to 74.3) |
The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| 1 year | 39.6 (30.4 to 48.8) | 40.7 (31.5 to 49.9) |
| 2 years | 44.2 (34.8 to 53.6) | 47.4 (38.0 to 56.8) |
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| Day 100 | 69.9 (60.1 to 78.6) | 71.0 (61.5 to 79.4) |
| 2 years | 48.5 (38.6 to 58.6) | 43.9 (34.3 to 53.9) |
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| Day 100 | 83.5 (76.2 to 90.8) | 82.2 (74.8 to 89.6) |
| Day 180 | 84.5 (77.4 to 91.6) | 83.2 (75.9 to 90.5) |
Hematologic function will be defined as ANC \> 1,500 neutrophils/μL, hemoglobin \> 10 g/dL without transfusion support, and platelet count \> 100,000/μL without transfusion support.
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| Day 100 | 34.8 (25.2 to 45.4) | 38.5 (28.8 to 49.0) |
| 1 year | 64.0 (52.1 to 74.8) | 58.9 (46.8 to 70.3) |
| participants | B-BEAM | R-BEAM |
|---|---|---|
| 1 Infection | 38 | 35 |
| 2 Infections | 14 | 11 |
| 3 Infections | 5 | 7 |
| 4 Infections | 3 | 4 |
| 5 Infections | 1 | 0 |
| 6-10 Infections | 6 | 2 |
| >10 Infections | 0 | 1 |
Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.
| scores on a scale | B-BEAM | R-BEAM |
|---|---|---|
| Mucositis Severity | 0.72 (0.00 to 2.00) | 0.31 (0.00 to 1.75) |
Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.
| cells/uL | B-BEAM | R-BEAM |
|---|---|---|
| CD2 (cells/uL) | 1006.0 ± 767.6 | 1024.9 ± 1074.7 |
| CD3 (cells/uL) | 921.8 ± 694.8 | 990.3 ± 1056.1 |
| CD4 (cells/uL) | 342.8 ± 223.9 | 286.1 ± 213.3 |
| CD8 (cells/uL) | 558.5 ± 517.9 | 697.7 ± 901.1 |
| CD19 (cells/uL) | 143.4 ± 140.5 | 140.8 ± 203.0 |
| CD3+/CD25+ (cells/uL) | 112.2 ± 92.8 | 118.0 ± 127.7 |
| CD45RA (cells/uL) | 469.3 ± 404.4 | 579.8 ± 620.5 |
| CD45RO (cells/uL) | 476.2 ± 337.4 | 727.8 ± 798.8 |
| CD56+/CD3- (cells/uL) | 125.1 ± 94.6 | 130.5 ± 135.7 |
Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.
| mg/dL | B-BEAM | R-BEAM |
|---|---|---|
| IgA (mg/dL) | 68.5 ± 42.6 | 85.0 ± 71.8 |
| IgG (mg/dL) | 619.6 ± 289.2 | 643.8 ± 395.3 |
| IgM (mg/dL) | 51.0 ± 36.0 | 79.0 ± 154.4 |
TRM is defined as death occurring in a patient from causes other than relapse or progression
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| 1 year | 5.9 (1.2 to 10.6) | 2.9 (0.0 to 6.0) |
| 2 years | 5.9 (1.2 to 10.6) | 3.9 (0.2 to 7.6) |
Time to neutrophil recovery will be the first of two consecutive days of \> 500 neutrophils/μL following the expected nadir.
| percentage of participants | B-BEAM | R-BEAM |
|---|---|---|
| Day 28 | 96.1 (92.2 to 100.0) | 93.5 (88.6 to 98.4) |
| Day 60 | 96.1 (92.2 to 100.0) | 95.3 (91.2 to 99.4) |
Collected over Patients will be followed for at least two years post-ASCT.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| B-BEAM | — | 11/111 (9.9%) | 0/111 (0%) |
| R-BEAM | — | 6/113 (5.3%) | 0/113 (0%) |
| Event | B-BEAM | R-BEAM |
|---|---|---|
| SyncopeNervous system disorders | 2/111 | 0/113 |
| Myocardial infarctionCardiac disorders | 0/111 | 2/113 |
| Acute graft versus host disease in liverImmune system disorders | 1/111 | 0/113 |
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/111 | 0/113 |
| Sinus tachycardiaCardiac disorders | 1/111 | 0/113 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/111 | 0/113 |
| CholecystitisHepatobiliary disorders | 1/111 | 0/113 |
| OrchidectomySurgical and medical procedures | 1/111 | 0/113 |
| Engraft failureInjury, poisoning and procedural complications | 1/111 | 0/113 |
| Cerebrovascular accidentNervous system disorders | 1/111 | 0/113 |
| Age, Continuous(years) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| Mean | 55.1 ± 13.5 | 56.8 ± 12.5 | 56.0 ± 13.0 |
| Sex: Female, Male(Participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| Female | 43 | 39 | 82 |
| Male | 68 | 74 | 142 |
| Ethnicity (NIH/OMB)(Participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 9 | 11 |
| Not Hispanic or Latino | 99 | 101 | 200 |
| Unknown or Not Reported | 10 | 3 | 13 |
| Race (NIH/OMB)(Participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 99 | 103 | 202 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Primary Disease Stage(participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| Primary Induction Failure | 21 | 15 | 36 |
| First Relapse | 35 | 46 | 81 |
| Second Complete Remission | 55 | 52 | 107 |
| Karnofsky Performance-status Score(participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| 100% | 29 | 26 | 55 |
| 90% | 67 | 63 | 130 |
| 80% | 12 | 19 | 31 |
| 70% | 3 | 5 | 8 |
| Disease Status at Transplantation(participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| First Partial Response | 21 | 15 | 36 |
| First Relapse | 35 | 45 | 80 |
| Second Complete Remission | 55 | 53 | 108 |
| Number of Prior Therapies(participants) | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| 1 | 2 | 7 | 9 |
| 2 | 93 | 83 | 176 |
| 3 | 16 | 23 | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).
Supporting information: Study protocol, Informed consent form
Time frame: Within 6 months of official study closure at participating sites.
Access criteria: Available to the public
Data sharing details ↗ · biolincc.nhlbi.nih.gov
The record gives a start of Dec 2005, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Heart, Lung, and Blood Institute (NHLBI) →