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 Details — Status: Completed

Administrative data

• NCT number: NCT00516152
• Other study ID #: UC-2214
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2007
• Last updated: January 22, 2009
• Start date: November 2002
• Est. completion date: November 2007

Study information

• Verified date: January 2009
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: UCSF Cancer Center Data Safety Monitoring Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 61 Years

Eligibility

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.

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

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

External Links

•   UCSF Cancer Center Home Page