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

NCT00516152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-01-26

No results posted yet for this study

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.

Conditions

  • Chronic Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • Myelodysplasia
  • Acute Lymphocytic Leukemia
  • Severe Aplastic Anemia
  • Non-Hodgkin's Lymphoma
  • Lymphoproliferative Disease
  • Multiple Myeloma
  • Advanced Myeloproliferative Disease

Interventions

DRUG

Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF

Day Preparative Regimen for GVHD Prophylaxis * 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 3 Fludarabine 30 mg/m(2)IV * 2 REST Tacrolimus 0.01 mg/kg CIVI * 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion * 1 Methotrexate 5mg/m(2)IV * 3 Methotrexate 5mg/m(2)IV * 6 Methotrexate 5mg/m(2)IV * 7 G-CSF 5mcg/kg SQ daily * 11 Methotrexate 5mg/m(2)IV * 90 Evaluate Response

Sponsors & Collaborators

Principal Investigators

  • Thomas G. Martin, M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00516152 on ClinicalTrials.gov