Clinical trial · Interventional
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Response rate
- measure
- Time to disease progression
- measure
- Toxicity
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated mantle cell lymphoma requiring therapy * Any stage PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2.5 times upper limit of normal (ULN)\^\* * Alkaline phosphatase no greater than 2.5 times ULN\^\* * Hepatitis B and hepatitis C negative NOTE: \*Unless related to lymphoma Renal * Creatinine no greater than 2.5 times ULN\^\* NOTE: \*Unless related to lymphoma Other * No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix * No prior psychological illness or condition that would preclude study compliance * No known hypersensitivity to murine proteins * No concurrent uncontrolled medical conditions * No other illness that would severely limit life expectancy * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (1)
- RESULTEve HE, Linch D, Qian W, Ross M, Seymour JF, Smith P, Stevens L, Rule SA. Toxicity of fludarabine and cyclophosphamide with or without rituximab as initial therapy for patients with previously untreated mantle cell lymphoma: results of a randomised phase II study. Leuk Lymphoma. 2009 Feb;50(2):211-5. doi: 10.1080/10428190802688509. PMID 19197729