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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00516152
First received: August 13, 2007
Last updated: January 22, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 36
Study Start Date: November 2002
Study Completion Date: November 2007
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   15 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516152

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco
  More Information

Additional Information:
UCSF Cancer Center Home Page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Beth Davis, University of California San Francisco
ClinicalTrials.gov Identifier: NCT00516152     History of Changes
Other Study ID Numbers: UC-2214
Study First Received: August 13, 2007
Last Updated: January 22, 2009
Health Authority: United States: UCSF Cancer Center Data Safety Monitoring Committee

Keywords provided by University of California, San Francisco:
Matched Unrelated Donor
Stem Cell Transplantation
Busulfan
fludarabine
Hematopoietic Disorder

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
 Myeloproliferative Disorders
Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Precancerous Conditions

ClinicalTrials.gov processed this record on June 18, 2013