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Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582933
First received: December 21, 2007
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Allogeneic Marrow Transplant
Intervention: Drug: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF

  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
No text entered.

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
Transplant Patients BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.

Participant Flow:   Overall Study
    Transplant Patients  
STARTED     95  
COMPLETED     92  
NOT COMPLETED     3  
Physician Decision                 3  



  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.
No text entered.

Reporting Groups
  Description
Transplant Patients BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.

Baseline Measures
    Transplant Patients  
Number of Participants  
[units: participants]
  92  
Age  
[units: years]
Median (Full Range)
  54.5  
  (0.6 to 71.3)  
Gender  
[units: participants]
 
Female     44  
Male     48  



  Outcome Measures

1.  Primary:   Death From GVHD   [ Time Frame: 2 years ]


  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: Dr. Farid Boulad
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-2429
e-mail: bouladf@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582933     History of Changes
Other Study ID Numbers: 01-055
CA23766
Study First Received: December 21, 2007
Results First Received: December 22, 2015
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board