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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00516152

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia Acute Myelogenous Leukemia Myelodysplasia Acute Lymphocytic Leukemia Severe Aplastic Anemia Non-Hodgkin's Lymphoma Lymphoproliferative Disease Multiple Myeloma Advanced Myeloproliferative Disease	Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2002

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 61 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

No fully or single-antigen mismatched sibling donor is available to donate stem cells.
Age >15 and <61
ECOG PS < or equal to 2
Adequate renal function with serum creatinine <2.0 mg/dl
Pulmonary diffusing capacity >40% of predicted
Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
Negative serology for the human immunodeficiency virus (HIV)
Available HLA-matched donor (see HLA compatibility requirements below)
Signed informed consent from the recipient

Exclusion Criteria:

Ongoing active infection
Pregnancy and/or nursing
Active, uncontrolled CNS leukemia
Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.