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Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders

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ClinicalTrials.gov Identifier: NCT00587054
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Allogeneic Stem Cell Transplant
Leukemia
Non-Hodgkins
Lymphoblastic Lymphoma
Myelodysplastic Syndrome
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Intervention: Drug: cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant

  Participant Flow

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
Transplant Patients Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine

Participant Flow:   Overall Study
    Transplant Patients
STARTED   129 
COMPLETED   120 
NOT COMPLETED   9 
Patient not treated                9 



  Baseline Characteristics

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
Transplant Patients Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine

Baseline Measures
   Transplant Patients 
Overall Participants Analyzed 
[Units: Participants]
 		 129 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      2   1.6% 
Between 18 and 65 years      127  98.4% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      51  39.5% 
Male      78  60.5% 


  Outcome Measures

1.  Primary:   Overall Survival of Transplant Patients   [ Time Frame: up to 6 years ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ann Jakubowski
Organization: Memorial Sloan-Kettering Cancer Center
phone: 212-639-5013
e-mail: jakubowa@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587054     History of Changes
Other Study ID Numbers: 01-070
CA23766
CA33049
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: December 22, 2015
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017