Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 28, 1998

Primary Completion Date

October 31, 2007

Study Completion Date

November 30, 2008

Conditions
Mantle Cell Lymphoma
Interventions
PROCEDURE

Intensive Induction-BMT

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, subjects 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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT00586755 - Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter