Clinical trial · Interventional
Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Randomized Trial Using Standard Dose Versus High Dose Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Diffuse Large B Cell Lymphomas
NCT00472056CI-TRIAL-00021362completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cohort 1: Patients who are less than or equal to 65 years of age. 1\. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) Cohort 2: Patients who are older than 65 years of age 1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) 2. To determine the treatment related mortality (TRM)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine | Drug | Carmustine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BEAM + Standard Rituximab
- description
- Arm 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Rituximab with Standard Rituximab for Cohort 1 or 2 Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Standard Rituximab: 375 mg/m\^2 IV Days +1, +8 after Stem Cell Infusion on Day 0.
- interventionNames
- Drug: Carmustine
- Drug: Etoposide
- Drug: Cytarabine
- Drug: Melphalan
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- BEAM + High Rituximab
- description
- BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. High Dose Rituximab: 1000 mg/m\^2 IV Days +1, +8 after Stem Cell Infusion on Day 0
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority 2. Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination 3. Age less than or equal to 80 years. There is no lower age limit for this study. 4. Zubrod performance status of less than 2 5. Negative pregnancy test in patients with child bearing potential 6. Must be willing to sign informed consent 7. Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody. Exclusion Criteria: 1. Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study. 2. Less than 3 weeks from last cytotoxic chemotherapy 3. Serum bilirubin \> 1.5 mg/dl 4. Serum transaminases \> 2X/ULN 5. Serum creatinine \> 1.6 mg/dl 6. Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight 7. Left ventricular ejection fraction of \< 40%, unless cleared by cardiology 8. Corrected DLCO of \< 50% 9. Patients who are on anticoagulants or antiplatelet agents.
References
Publications (0)
Data not yet available
No reference posted for this study.