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Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

This study is currently recruiting participants.
Verified July 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00943319
First received: July 20, 2009
Last updated: July 22, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is:

  1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion.
  2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
  3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen.
  4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.

Condition Intervention Phase
Leukemia
Lymphoma
Myeloma
 Drug: Busulfan
Drug: Fludarabine
Drug: Campath
Procedure: Stem Cell Transplant
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate disease free and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Busulfan
    Daily intravenous dosing to target AVC
    Drug: Fludarabine
    Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
    Drug: Campath
    All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).
    Procedure: Stem Cell Transplant
    Infusion of bone marrow and donors(related/ unrelated).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Phase I portion:

  • Relapsed or refractory acute myelogenous or lymphoid leukemia.
  • Chronic myelogenous leukemia in accelerated phase or blast-crisis.
  • Recurrent or refractory malignant lymphoma or Hodgkin's disease
  • Recurrent or refractory multiple myeloma.
  • Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
  • Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
  • Myelodysplastic syndromes with more than 5% blasts.

Phase II portion:

  • AML with active disease or beyond CR2.
  • MDS with more than 5% blasts.

Exclusion Criteria:

  • Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943319

Contacts
Contact: Andrew Artz, MD 773-834-8980 aartz@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Andrew Artz, M.D.     773-834-8980        
Contact: Paula Del Cerro, RN     773-702-2070     pdelcerr@medicine.bsd.uchicago.edu    
Principal Investigator: Koen van Besien, M.D.            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Andrew Artz, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrew Artz, MD, Associate Professor, Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00943319     History of Changes
Other Study ID Numbers: 12-0132
Study First Received: July 20, 2009
Last Updated: July 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Cancers of the blood

Additional relevant MeSH terms:
Leukemia
Lymphoma
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Busulfan
Fludarabine monophosphate
Fludarabine
 Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on June 17, 2013