A Phase II Study of Yttrium-90-Labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Beam (BCNU, Etoposide, Cytarabine and Melphalan) Followed by Autologous Stem Cell Transplantation for Patients With Poor Risk/Relapsed B-Cell Lymphoma
PRIMARY OBJECTIVES: I. To estimate the progression free/relapse free survival and overall
survival probabilities among patients with poor risk/relapsed follicular lymphoma (grade
1-3), mantle cell lymphoma, diffuse large B-cell lymphoma, and transformed low-grade
lymphoma who undergo RIT based autologous stem cell transplant (ASCT). II. To evaluate
hematopoietic recovery, using neutrophil (absolute neutrophil count [ANC] >= 500 x 10^3/ul,
ANC >= 1000 x 10^3/ul) and unmaintained platelet (>= 20 x 10^3/ul, >= 100 x 10^3/ul)
engraftment as primary criterion, following RIT based ASCT. III. To characterize early and
late pulmonary, cardiac and hepatic toxicities during the first 100 days post ASCT and again
one year post ASCT. IV. To evaluate the response rate and the disease progression/relapse
rate in patients treated with RIT based ASCT. V. To evaluate long-term incidence of
myelodysplasia and therapy related AML with this new preparative regimen. VI. To
descriptively compare the outcomes of patients treated on this protocol to a comparable
patient population treated with chemotherapy alone. VII. To perform exploratory studies on
expression of costimulatory molecules before and after RIT based ASCT.
OUTLINE: RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan
intravenously (IV) following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY:
Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and
cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM
CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on
day 0. Patients also receive rituximab on day 8*. NOTE: * Some patients may also receive
rituximab on day -1. Treatment continues in the absence of disease progression or
unacceptable toxicity. After completion of study treatment, patients are followed up
periodically.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)/relapse-free survival
2 years after treatment
No
Amrita Y. Krishnan, MD
Principal Investigator
City of Hope Medical Center
United States: Institutional Review Board
07076
NCT00695409
March 2008
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |