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Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00134004
First received: August 22, 2005
Last updated: September 2, 2015
Last verified: September 2015
Results First Received: June 26, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions: Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy

  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
Mini-haplo BMT Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.

Participant Flow:   Overall Study
    Mini-haplo BMT
STARTED   210 
COMPLETED   210 
NOT COMPLETED   0 



  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
Mini-haplo BMT Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.

Baseline Measures
   Mini-haplo BMT 
Overall Participants Analyzed 
[Units: Participants]
 210 
Age 
[Units: Years]
Mean (Full Range)
 52 
 (1 to 73) 
Gender 
[Units: Participants]
 
Female   61 
Male   149 
Region of Enrollment 
[Units: Participants]
 
United States   210 


  Outcome Measures
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1.  Primary:   Transplant-related Mortality   [ Time Frame: Cumulative incidence for the entire study, up to 11 years ]

2.  Primary:   Relapse Rate   [ Time Frame: Cumulative incidence for the entire study, up to 11 years ]

3.  Primary:   Progression-free Survival   [ Time Frame: 2 years ]

4.  Secondary:   Graft Failure Rate   [ Time Frame: Cumulative incidence for the entire study, up to 11 years ]

5.  Secondary:   Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation   [ Time Frame: 1 year ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ephraim Fuchs
Organization: Johns Hopkins University
phone: 410-419-6479
e-mail: fuchsep@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00134004     History of Changes
Other Study ID Numbers: J0457 CDR0000440990
P01CA015396 ( US NIH Grant/Contract Award Number )
P30CA006973 ( US NIH Grant/Contract Award Number )
JHOC-J0457 ( Other Identifier: Johns Hopkins SKCCC )
JHOC-04072704
Study First Received: August 22, 2005
Results First Received: June 26, 2015
Last Updated: September 2, 2015
Health Authority: United States: Food and Drug Administration