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High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas.

ABSTRACT: Relapse after autologous stem cell transplant for low grade B-cell lymphoma is common secondary to ineffective conditioning and/or tumor autograft contamination. We investigated high-dose cyclophosphamide and rituximab without stem cell rescue as first-line or salvage therapy in lymphomas. After establishing safety, accrual was increased to evaluate event-free survival (EFS). Eighty-one adults received rituximab (375 mg/m(2) days 1, 4, 8, 11, 45, 52), cyclophosphamide (50 mg/kg days 15-18), and pegfilgrastim (day 20). Forty-two patients had low grade B-cell lymphoma [grade I/II follicular (69%), transformed lymphoma (17%), other (15%)]: 45% were treated without measurable disease. Thirty-nine patients had mantle cell lymphoma: 82% were treated without measurable disease. All achieved hematopoietic recovery; 46% required brief hospitalizations. The 5-year EFS and overall survival (OS) for patients with low grade B-cell and transformed lymphoma were 40% and 72%, respectively. The 5-year EFS and OS for patients with MCL were 39% and 62%, respectively. This low-toxicity therapeutic approach obviates the need for stem cell products and establishes a platform for future therapies.

SUBMITTER: Gladstone DE

PROVIDER: S-EPMC3390263 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas.

Gladstone Douglas E DE Bolaños-Meade Javier J Huff Carol Ann CA Zahurak Marianna M Flinn Ian I Borrello Ivan I Luznik Leo L Fuchs Ephraim E Kasamon Yvette Y Matsui William W Powell Jonathan J Levitsky Hyam H Brodsky Robert A RA Ambinder Richard R Jones Richard J RJ Swinnen Lode J LJ

Leukemia & lymphoma 20110714 11

Relapse after autologous stem cell transplant for low grade B-cell lymphoma is common secondary to ineffective conditioning and/or tumor autograft contamination. We investigated high-dose cyclophosphamide and rituximab without stem cell rescue as first-line or salvage therapy in lymphomas. After establishing safety, accrual was increased to evaluate event-free survival (EFS). Eighty-one adults received rituximab (375 mg/m(2) days 1, 4, 8, 11, 45, 52), cyclophosphamide (50 mg/kg days 15-18), and ...[more]

PMID: 21756035

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Project description:BackgroundMantle-cell lymphoma is generally incurable. Initial treatment is not standardized but usually includes cytotoxic chemotherapy. Lenalidomide, an immunomodulatory compound, and rituximab, an anti-CD20 antibody, are active in patients with recurrent mantle-cell lymphoma. We evaluated lenalidomide plus rituximab as a first-line therapy.MethodsWe conducted a single-group, multicenter, phase 2 study with induction and maintenance phases. During the induction phase, lenalidomide was administered at a dose of 20 mg daily on days 1 through 21 of every 28-day cycle for 12 cycles; the dose was escalated to 25 mg daily after the first cycle if no dose-limiting adverse events occurred during the first cycle and was reduced to 15 mg daily during the maintenance phase. Rituximab was administered once weekly for the first 4 weeks and then once every other cycle until disease progression. The primary end point was the overall response rate. Secondary end points included outcomes related to safety, survival, and quality of life.ResultsA total of 38 participants were enrolled at four centers from July 2011 through April 2014. The median age was 65 years. On the basis of the Mantle Cell Lymphoma International Prognostic Index scores, the proportions of participants with low-risk, intermediate-risk, and high-risk disease at baseline were similar (34%, 34%, and 32%, respectively). The most common grade 3 or 4 adverse events were neutropenia (in 50% of the patients), rash (in 29%), thrombocytopenia (in 13%), an inflammatory syndrome ("tumor flare") (in 11%), anemia (in 11%), serum sickness (in 8%), and fatigue (in 8%). At the median follow-up of 30 months (through February 2015), the overall response rate among the participants who could be evaluated was 92% (95% confidence interval [CI], 78 to 98), and the complete response rate was 64% (95% CI, 46 to 79); median progression-free survival had not been reached. The 2-year progression-free survival was estimated to be 85% (95% CI, 67 to 94), and the 2-year overall survival 97% (95% CI, 79 to 99). A response to treatment was associated with improvement in quality of life.ConclusionsCombination biologic therapy consisting of lenalidomide plus rituximab was active as initial therapy for mantle-cell lymphoma. (Funded by Celgene and Weill Cornell Medical College; ClinicalTrials.gov number, NCT01472562.).

Dataset Information

High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas.

Publications

High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas.

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