Clinical trial · Interventional
VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL
A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies
- 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: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Rituxan + Etoposide + G-CSF
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- type
- OTHER
- label
- Etoposide + G-CSF
- interventionNames
- Biological: filgrastim
Primary outcomes (2)
- measure
- Correlate CD34+ cell yields with the addition of rituximab
- timeFrame
- At least two weeks prior to transplant
- measure
- Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria: * Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL) * Patients with B-cell NHL in first remission and who have significant risk for later relapse * Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation PATIENT CHARACTERISTICS: * Life expectancy at least 2 months * Cardiac ejection fraction ≥ 45% * DLCO ≥ 45% * Creatinine \< 2.0 mg/dL * Bilirubin \< 2.0 mg/dL * AST \< 2 times normal * Platelet count ≥ 50,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Absolute lymphocyte count ≤ 10,000/mm\^3 * HIV negative * No severe medical or psychiatric illnesses * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * More than 8 weeks since prior rituximab
References
Publications (1)
- RESULTCopelan E, Pohlman B, Rybicki L, Kalaycio M, Sobecks R, Andresen S, Dean R, Koo A, Chan J, Sweetenham J, Bolwell B. A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin's lymphoma. Bone Marrow Transplant. 2009 Jan;43(2):101-5. doi: 10.1038/bmt.2008.306. Epub 2008 Sep 15. PMID 18794865