Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)

This study has been terminated.
(slow accrual)
Sponsor:
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital System
Information provided by (Responsible Party):
Rammurti Kamble, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00579111
First received: December 19, 2007
Last updated: July 3, 2012
Last verified: July 2012
Results First Received: July 3, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic and Myeloproliferative Disorders
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Multiple Myeloma
Plasma Cell Dyscrasia
Lymphoproliferative Disorders
Hematologic Diseases
Interventions: Drug: Campath
Drug: Busulfan
Drug: Fludarabine
Procedure: Hematopoietic stem cell infusion
Drug: FK-506

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HLA-identical Sibling Transplant Recipients of HLA identical sibling stem cell transplants
Unrelated Matched or Single Antigen Mismatched Transplant Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants

Participant Flow:   Overall Study
    HLA-identical Sibling Transplant     Unrelated Matched or Single Antigen Mismatched Transplant  
STARTED     3     1  
COMPLETED     1     0  
NOT COMPLETED     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
HLA-identical Sibling Transplant Recipients of HLA identical sibling stem cell transplants
Unrelated Matched or Single Antigen Mismatched Transplant Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
Total Total of all reporting groups

Baseline Measures
    HLA-identical Sibling Transplant     Unrelated Matched or Single Antigen Mismatched Transplant     Total  
Number of Participants  
[units: participants]
  3     1     4  
Age, Customized  
[units: participants]
     
Between 50 and 65 years     3     0     3  
>=65 years     0     1     1  
Gender  
[units: participants]
     
Female     1     0     1  
Male     2     1     3  



  Outcome Measures
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1.  Primary:   Number of Patients With Successful Donor Engraftment   [ Time Frame: 100 days ]

2.  Secondary:   Number of Treatment Related Grade III or IV Non-hematological Toxicity   [ Time Frame: 100 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rammurti Kamble, MD
Organization: Baylor
phone: 713-394-6252
e-mail: rtkamble@tmhs.org


No publications provided


Responsible Party: Rammurti Kamble, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00579111     History of Changes
Obsolete Identifiers: NCT00625144
Other Study ID Numbers: 19386, FAB
Study First Received: December 19, 2007
Results First Received: July 3, 2012
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration