Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00516152
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : January 26, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 13, 2007
First Posted Date  ICMJE August 15, 2007
Last Update Posted Date January 26, 2009
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00516152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT
Official Title  ICMJE Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • Myelodysplasia
  • Acute Lymphocytic Leukemia
  • Severe Aplastic Anemia
  • Non-Hodgkin's Lymphoma
  • Lymphoproliferative Disease
  • Multiple Myeloma
  • Advanced Myeloproliferative Disease
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August¬†13,¬†2007)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 61 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00516152
Other Study ID Numbers  ICMJE UC-2214
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beth Davis, University of California San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP