Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma
Patients will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2
Intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d
intravenously over 30 minutes daily on days 1, 2, and 3). This will be combined with
Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, patients have not
had progression of disease as noted on physical exam or radiographic scans, they will
proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed
by high dose therapy with stem cell support. Following count recovery, rituximab will be
used for 8 total doses as consolidation therapy. Involved field irradiation may be given
post-transplant to those with localized bulky disease as well. Day -6: Carmustine (BCNU): 15
mg/kg (or 550 mg/m2) IV over 2 hrs. Day -4: Etoposide Day -2: Cyclophosphamide 100 mg/kg in
1 liter D5W over 2 hours.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the efficacy in terms of duration of response of intensive induction therapy followed by high dose ablative therapy with autologous progenitor cell support
2 years
No
David Rizzieri, MD
Principal Investigator
Duke University Health Systems
United States: Institutional Review Board
2165
NCT00586755
February 1998
November 2008
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