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

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: NCT00943319
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Lymphoma Myeloma Drug: Busulfan Drug: Fludarabine Drug: Campath Procedure: Stem Cell Transplant Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Busulfan and fludarabine
Intravenous busulfan (Busulfan®) in combination with fludarabine
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).




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 5 years ]
    Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    Overall Survival measured as median survival in days

  2. Disease Free Survival [ Time Frame: 5 years ]
    Disease Free Survival measured by median survival time in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943319


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Andrew Artz, MD University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00943319    
Other Study ID Numbers: 12-0132
First Posted: July 22, 2009    Key Record Dates
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019
Last Verified: February 2019
Keywords provided by University of Chicago:
Cancers of the blood
Additional relevant MeSH terms:
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Neoplasms
Vidarabine
Fludarabine
Fludarabine phosphate
Busulfan
Alemtuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists
Antineoplastic Agents, Immunological