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Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

Multiple Myeloma Clinical Trial

Official title:
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation

Clinical Trial Summary

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Acute Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • Advanced Myeloproliferative Disease
  • Anemia, Aplastic
  • Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disease
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Myelodysplasia
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders
  • Non-Hodgkin's Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Severe Aplastic Anemia
Clinical Trial Details
NCT number NCT00516152
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date November 2002
Completion date November 2007
View Details
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