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Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor

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ClinicalTrials.gov Identifier: NCT01598025
Recruitment Status : Terminated (Closed due to poor accrual)
First Posted : May 15, 2012
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Leukemia
Chronic Leukemia
Myelodysplastic Syndrome
Non-Hodgkins Lymphoma
Interventions: Radiation: total-body irradiation (TBI)
Drug: thiotepa
Drug: fludarabine phosphate
Drug: melphalan
Biological: anti-thymocyte globulin
Procedure: allogeneic hematopoietic stem cell transplantation
Biological: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis

  Participant Flow

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
No text entered.

Reporting Groups
  Description
REGIMEN 1

REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

total-body irradiation (TBI)

thiotepa

fludarabine phosphate

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis

Regimen 2

To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

thiotepa

fludarabine phosphate

melphalan

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis


Participant Flow:   Overall Study
    REGIMEN 1   Regimen 2
STARTED   0   3 
COMPLETED   0   0 
NOT COMPLETED   0   3 



  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.
No text entered.

Reporting Groups
  Description
REGIMEN 1

REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

total-body irradiation (TBI)

thiotepa

fludarabine phosphate

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis

Regimen 2

To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.

TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.

thiotepa

fludarabine phosphate

melphalan

anti-thymocyte globulin

allogeneic hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

laboratory biomarker analysis

Total Total of all reporting groups

Baseline Measures
   REGIMEN 1   Regimen 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   3   3 
Age 
[Units: Years]
Median (Full Range)
    12 
 (11 to 17) 
 12 
 (11 to 17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   0      1  33.3%      1  33.3% 
Male   0      2  66.7%      2  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   0      0   0.0%      0   0.0% 
Not Hispanic or Latino   0      3 100.0%      3 100.0% 
Unknown or Not Reported   0      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   0      0   0.0%      0   0.0% 
Asian   0      2  66.7%      2  66.7% 
Native Hawaiian or Other Pacific Islander   0      0   0.0%      0   0.0% 
Black or African American   0      0   0.0%      0   0.0% 
White   0      1  33.3%      1  33.3% 
More than one race   0      0   0.0%      0   0.0% 
Unknown or Not Reported   0      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   0   3   3 


  Outcome Measures

1.  Primary:   Efficacy   [ Time Frame: 1 year ]

2.  Secondary:   Evaluate Recipients Post Transplant   [ Time Frame: 1 year ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Richard O'Reilly, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-2157
e-mail: oreillyr@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01598025     History of Changes
Other Study ID Numbers: 12-053
First Submitted: May 9, 2012
First Posted: May 15, 2012
Results First Submitted: March 19, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018