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Treatment of Follicular and Mantle Cell Lymphoma with Rituximab after High-Dose Chemotherapy and Autologous Blood Stem Cell Transplantation A Multicenter Phase II Study



Treatment of Follicular and Mantle Cell Lymphoma with Rituximab after High-Dose Chemotherapy and Autologous Blood Stem Cell Transplantation A Multicenter Phase II Study



Blood 100(11): Abstract No 2532, November 16



Introduction: Between October 1997 and July 2001, we performed a multicenter phase II study (M39005) to investigate the safety and efficacy of rituximab after high-dose therapy (HDT) and autologous peripheral blood stem cell transplantation (PBSCT) in patients with follicular (FL) and mantle cell lymphoma (MCL). The primary objective was to evaluate the progression free survival at 2 years after transplantation. Methods: Eligibility included newly diagnosed stage III/IV t(14;18)+ FL or newly diagnosed or relapsed patients with stage III/IV t(11;14)+ MCL. Initial chemotherapy consisted of VACOP-B (6 weeks) or CHOP, followed by G-CSF supported VIP-E or DexaBEAM chemotherapy. PBSC were harvested, and positive selection of CD34+ cells was performed. HDT consisted of TBI (6x2 Gy) and cyclophosphamide (120 mg/kg), followed by CD34+ PBSCT (7.16x10e6 CD34+/kg; range 2.4-22.7). After a median of 63 days (38-108 days) after transplantation, rituximab was given at a dose of 375 mg/m2 weekly for 4 weeks. Sequential monitoring of minimal residual disease (MRD) before and after HDT and rituximab treatment was performed in peripheral blood (PB) and/or bone marrow (BM) by PCR. Results: 31 patients were included; one patient died after HDT before rituximab treatment, and 30 patients (FL n=20, MCL n=10) are evaluable for safety and efficacy as of July 01, 2002. Twenty seven patients are evaluable for MRD. Median age was 49 (31-60) years. Rituximab treatment after HDT was generally well tolerated; the most common WHO grade III-IV toxicity was infection (n=6), most likely related to a B- and T-cell deficiency lasting for approximately 9-12 months after transplantation. 12 severe adverse events were observed: 11 re-hospitalisations for pneumonias, FUO, fatigue or suspected myocarditis, and one patient died at day +27 after HDT (interstitial pneumonitis) but before rituximab treatment. At a median follow- up of 24 months (3-49 months) after transplantation, 29/30 patients are in clinical complete remission (CR). One patient with MCL relapsed at 24 months after transplantation. CR-rates developed over time with 57% at 6 months and 88% at 12 months, respectively. Prior to HDT, 22% of the patients PB and/or BM samples were PCR-negative. These numbers converted to 53% PCR negativity after HDT (p=0.0547), 72% at 4 weeks after rituximab (p=0.0018), and 100% at 6 months post transplantation (p<0.001). One patient became transiently PCR-positive during follow-up, another patient was tested PCR-positive in BM but negative in PB at the 12 month follow-up. Conclusion: rituximab treatment after HDT is safe and effective, but close monitoring for infections is necessary. Rituximab is able to eliminate MRD after HDT and bring about high rates of durable remissions, suggesting that this approach might improve both progression-free and overall survival.

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Accession: 035980411

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