Trial · NCT00329030
Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)
NCT00329030, Phase 3, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2016-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401). Trials, record NCT00329030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00329030
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)
- NCT number
- NCT00329030
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Lymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Non-Hodgkin
- Interventions
- Autologous transplantation using rituxan/BEAM, Autologous transplantation using Bexxar/BEAM
- First posted
- 2006-05-24
- Last updated
- 2021-11-01
- Results first posted
- 2016-06-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 1 and 2 years | 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. |
| Secondary | Overall Survival | 1 and 2 years | 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 |
| Secondary | Incidence of Relapse/Progression | 1 and 2 years | 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. |
| Secondary | Complete Response (CR) and Partial Response (PR) Proportion | Day 100 and 2 years | |
| Secondary | Platelet Recovery to 20,000 Cells/μL | 100 and 180 days | |
| Secondary | Hematologic Function | 100 days, 1 year | 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. |
| Secondary | Incidence of Infection | 1 year | |
| Secondary | Mucositis Severity | Day 21 | 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. |
| Secondary | Immune Reconstitution | 1 year | Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-. |
| Secondary | Immune Reconstitution of Quantitative Immunoglobulins | 1 year | Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | 1 and 2 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | 1 and 2 years | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Relapse/Progression | 1 and 2 years | percentage of participants | NUMBER | |
| SECONDARY | Complete Response (CR) and Partial Response (PR) Proportion | Day 100 and 2 years | percentage of participants | NUMBER | |
| SECONDARY | Platelet Recovery to 20,000 Cells/μL | 100 and 180 days | percentage of participants | NUMBER | |
| SECONDARY | Hematologic Function | 100 days, 1 year | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Infection | 1 year | 67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections. | participants | NUMBER |
| SECONDARY | Mucositis Severity | Day 21 | scores on a scale | MEDIAN | |
| SECONDARY | Immune Reconstitution | 1 year | cells/uL | MEAN | |
| SECONDARY | Immune Reconstitution of Quantitative Immunoglobulins | 1 year | mg/dL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | B-BEAM | 1 year | 53.2 | 95% Confidence Interval 43.5 to 61.9 | percentage of participants |
| Progression-free Survival (PFS) | R-BEAM | 1 year | 56.6 | 95% Confidence Interval 46.8 to 65.2 | percentage of participants |
| Progression-free Survival (PFS) | B-BEAM | 2 years | 48.6 | 95% Confidence Interval 39.0 to 57.5 | percentage of participants |
| Progression-free Survival (PFS) | R-BEAM | 2 years | 49.0 | 95% Confidence Interval 39.3 to 58.0 | percentage of participants |
| Overall Survival | B-BEAM | 1 year | 68.5 | 95% Confidence Interval 58.9 to 76.2 | percentage of participants |
| Overall Survival | R-BEAM | 1 year | 73.7 | 95% Confidence Interval 64.4 to 80.9 | percentage of participants |
| Overall Survival | B-BEAM | 2 years | 60.1 | 95% Confidence Interval 50.3 to 68.6 | percentage of participants |
| Overall Survival | R-BEAM | 2 years | 66.3 | 95% Confidence Interval 56.6 to 74.3 | percentage of participants |
| Incidence of Relapse/Progression | B-BEAM | 1 year | 39.6 | 95% Confidence Interval 30.4 to 48.8 | percentage of participants |
| Incidence of Relapse/Progression | R-BEAM | 1 year | 40.7 | 95% Confidence Interval 31.5 to 49.9 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | B-BEAM | 111 | |
| Overall Study | STARTED | R-BEAM | 113 | |
| Overall Study | COMPLETED | B-BEAM | 103 | |
| Overall Study | COMPLETED | R-BEAM | 107 | |
| Overall Study | NOT COMPLETED | B-BEAM | 8 | |
| Overall Study | NOT COMPLETED | R-BEAM | 6 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute graft versus host disease in liver | Immune system disorders | B-BEAM | 1 | 111 | 1 |
| serious | Acute graft versus host disease in liver | Immune system disorders | R-BEAM | 0 | 113 | 0 |
| serious | Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | B-BEAM | 1 | 111 | 1 |
| serious | Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | R-BEAM | 0 | 113 | 0 |
| serious | Syncope | Nervous system disorders | B-BEAM | 2 | 111 | 2 |
| serious | Syncope | Nervous system disorders | R-BEAM | 0 | 113 | 0 |
| serious | Sinus tachycardia | Cardiac disorders | B-BEAM | 1 | 111 | 1 |
| serious | Sinus tachycardia | Cardiac disorders | R-BEAM | 0 | 113 | 0 |
| serious | Pneumonitis | Respiratory, thoracic and mediastinal disorders | B-BEAM | 1 | 111 | 1 |
| serious | Pneumonitis | Respiratory, thoracic and mediastinal disorders | R-BEAM | 0 | 113 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | B-BEAM | ||
| Total, all-cause mortality | R-BEAM | ||
| Total, other adverse events | B-BEAM | 0 | 111 |
| Total, other adverse events | R-BEAM | 0 | 113 |
| Total, serious adverse events | B-BEAM | 11 | 111 |
| Total, serious adverse events | R-BEAM | 6 | 113 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23478060 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL069294 | BMT Clinical Research Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| B-BEAM vs R-BEAM: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00329030
GET https://conductscience.org/api/trials/v1/NCT00329030/results?page=2