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

Primary Purpose

Chronic Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Matched Unrelated Donor, Stem Cell Transplantation, Busulfan, fludarabine, Hematopoietic Disorder

Eligibility Criteria

15 Years - 61 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of California San Francisco

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 13, 2007
Last Updated
January 22, 2009
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00516152
Brief Title
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplasia, Acute Lymphocytic Leukemia, Severe Aplastic Anemia, Non-Hodgkin's Lymphoma, Lymphoproliferative Disease, Multiple Myeloma, Advanced Myeloproliferative Disease
Keywords
Matched Unrelated Donor, Stem Cell Transplantation, Busulfan, fludarabine, Hematopoietic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF
Intervention Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G. Martin, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.ucsf.edu
Description
UCSF Cancer Center Home Page

Learn more about this trial

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

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