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

NCT ID: NCT00516152

Last Updated: 2009-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2007-11-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California San Francisco

Principal Investigators

Thomas G. Martin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Related Links

http://cancer.ucsf.edu

UCSF Cancer Center Home Page

Other Identifiers

UC-2214

Identifier Type: -

Identifier Source: org_study_id