Clinical trial · Interventional
Rituximab & Combination Chemotherapy Followed by Transplantation in Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Rituxan and BEAM with autologous stem cell transplant
- interventionNames
- Biological: rituximab
- Drug: carmustine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Procedure: autologous hematopoietic stem cell transplantation
Primary outcomes (1)
- measure
- 100 day (complete + partial) response rate
- timeFrame
- 100 days
- description
- The primary endpoint for this study is 100 day (complete + partial) response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma * Transplantation candidate * Primary induction failure * Chemotherapy refractory disease * Received at least 3 prior chemotherapy regimens or diagnosis of mantle cell lymphoma * Age 19 and over * Performance status: WHO 0-2 * Life expectancy at least 6 months * Absolute neutrophil count at least 1,000/mm3 (unless due to lymphomatous involvement of the marrow) * Platelet count more than 50,000/mm3 (unless due to lymphomatous involvement of the marrow) * Hemoglobin more than 9.0 g/dL (unless due to lymphomatous involvement of the marrow) * Fertile patients must use effective contraception * Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed Exclusion Criteria: * No other concurrent chemotherapy * No concurrent corticosteroids except for transient control or prevention of nausea or vomiting * No concurrent external beam radiotherapy during transplantation therapy * No other concurrent antitumoral or investigational agents * No history of T-cell lymphoma * No relapse or progression after rituximab therapy within 3 months before transplantation * No serious disease or condition that would preclude study * Not pregnant or nursing/negative pregnancy test
References
Publications (0)
Data not yet available