Clinical trial · Interventional
Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma
A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma
- 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)
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Arm 1
- description
- Participants receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest. Participants then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Participants undergo autologous hematopoietic stem cell transplantation on day 0. Participants who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks. Participants are followed at day 100, at 1 year, and then annually thereafter.
- interventionNames
- Biological: rituximab
- Drug: carmustine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Procedure: autologous bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-Hodgkin's lymphoma o Any B cell * CD20-positive disease * Failed prior primary induction therapy * Meets 1 of the following criteria: * Chemotherapy-refractory disease * Received at least 3 prior chemotherapy regimens * Mantle cell lymphoma * Eligible for transplantation * 19 years old and over * WHO 0-2 * Life expectancy at least 6 months * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count \> 50,000/mm\^3\* * Hemoglobin \> 9.0 g/dL\* o NOTE: \*Unless due to lymphomatous involvement of the bone marrow * Fertile patients must use 2 methods of effective contraception Exclusion Criteria: * No history of T-cell lymphoma * Not pregnant or nursing * No other concurrent serious disease or condition that would preclude study participation
References
Publications (0)
Data not yet available