Clinical trial · Interventional
Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell 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 block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-HiCy
- description
- Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
- interventionNames
- Biological: Pegfilgrastim
- Biological: Rituximab
- Drug: Cyclophosphamide
Primary outcomes (3)
- measure
- Engraftment
- timeFrame
- Up to 43 days
- description
- Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.
- measure
- Non-relapse Mortality
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * One of the following B-cell leukemias or lymphomas, as defined by World Health Organization criteria: * Chronic lymphocytic leukemia/small lymphocytic lymphoma * B-cell prolymphocytic leukemia * Lymphoplasmacytic leukemia * Marginal zone lymphoma (splenic, extranodal, or nodal) * Follicular lymphoma (grade 1 or 2) * Mantle cell lymphoma * No more than minimal (approximately 10%) morphologically identifiable cancer cells on bone marrow biopsy * When cancer cells are morphologically difficult to distinguish from normal cells, flow cytometry must show no more than 10% identifiable cancer cells * Must have received ≤ 12 months of prior cytotoxic therapy, achieving at least a partial response NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 * Serum creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 2 mg/dL unless secondary to tumor * AST or ALT \< 2 times upper limit of normal * Normal (≥ 45%) left ventricular cardiac ejection fraction (determined by echocardiogram or MUGA scan) * DLCO \> 50% predicted * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known sensitivity to E. coli-derived products (e.g. filgrastim \[G-CSF\], insulin, asparaginase, growth hormone, or recombinant interferon alfa-2b) or any treatment study drugs * No active infections requiring oral or intravenous antibiotics * No other second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix unless the malignancy was localized and treated or resected with \> 90% probability of cure PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior anti-CD20 therapy allowed provided patient achieved a partial or complete response * No concurrent steroids during rituximab administration
References
Publications (1)
- RESULTGladstone DE, Bolanos-Meade J, Huff CA, Zahurak M, Flinn I, Borrello I, Luznik L, Fuchs E, Kasamon Y, Matsui W, Powell J, Levitsky H, Brodsky RA, Ambinder R, Jones RJ, Swinnen LJ. High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas. Leuk Lymphoma. 2011 Nov;52(11):2076-81. doi: 10.3109/10428194.2011.594191. Epub 2011 Jul 14. PMID 21756035