Clinical trial · Interventional
Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma
Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell 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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation. PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: with rituximab IV
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- Drug: carmustine
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: etoposide
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm II: without rituximab IV
- interventionNames
- Biological: filgrastim
- Drug: carmustine
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: etoposide
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) * Indolent or aggressive histology * No small lymphocytic lymphoma, Burkitt's lymphoma, or small lymphocytic non-Burkitt's lymphoma * CD20-positive and/or CD19-positive by immunohistochemistry or flow cytometry * Second or greater remission allowed * Partial remission, relapse, or refractory disease must have measurable tumor * Eligible for high-dose therapy followed by autologous peripheral blood stem cell transplantation * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 12 to 65 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,200/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Creatinine clearance at least 60 mL/min * No renal dysfunction Cardiovascular: * LVEF at least 40% * No cardiac dysfunction * No myocardial infarction within the past 3 months Pulmonary: * FEV\_1 greater than 60% * DLCO at least 60% of predicted * No pulmonary dysfunction * No asthma Other: * HIV negative * No significant organ dysfunction * No severe comorbid condition * No uncontrolled diabetes * No severe or active infection * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No prior immunotherapy Chemotherapy: * No prior high-dose chemotherapy with or without peripheral blood stem cell transplantation * No more than 3 prior chemotherapy regimens for NHL * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy allowed Surgery: * Not specified
References
Publications (0)
Data not yet available