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Trial record 85 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

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 : August 9, 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
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title REGIMEN 1 Regimen 2
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 0 3
Completed 0 0
Not Completed 0 3
Arm/Group Title REGIMEN 1 Regimen 2 Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 0 3 3
Hide Baseline Analysis Population Description
Zero participants were enrolled to Regimen 1
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 0 participants 3 participants 3 participants
12
(11 to 17)
12
(11 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 3 participants 3 participants
Female 0
1
  33.3%
1
  33.3%
Male 0
2
  66.7%
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 3 participants 3 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 3 participants 3 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 0 participants 3 participants 3 participants
0
3
 100.0%
3
 100.0%
1.Primary Outcome
Title Efficacy of HLA-haploidentical Biparental T-cell Depleted CD34+ Peripheral Blood Stem Cell Transplants
Hide Description

Efficacy is measured by:

  1. incidence of transplant-related mortality, overall survival and disease-free survival at 1 year post transplant.
  2. incidence, tempo and complications of engraftment and hematopoietic reconstitutions and conversely, the risk of graft failure
  3. incidence and severity of acute and/or chronic GVHD
  4. incidence and severity of opportunistic infections developing following engraftment
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.
Arm/Group Title REGIMEN 1 Regimen 2
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Evaluation of Recipients Post Transplant
Hide Description The levels of engraftment and persistence of hematopoietic cells and their myeloid and lymphoid progressing from each donor post transplant. The tolerance or reactivity of engrafted T cells from each donor detected in the blood at 3, 6, and thereafter every 3-6 months until normal, post transplant against host cells and cells derived from the other parent as measured by standard mixed lymphocyte culture and cell mediated cytolysis assays.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.
Arm/Group Title REGIMEN 1 Regimen 2
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 24 months after transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regimen 2
Hide Arm/Group Description

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.

All-Cause Mortality
Regimen 2
Affected / at Risk (%)
Total   3/3 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Regimen 2
Affected / at Risk (%)
Total   2/3 (66.67%) 
Cardiac disorders   
Sinus tachycardia  1  1/3 (33.33%) 
Gastrointestinal disorders   
Pancreatitis  1  1/3 (33.33%) 
General disorders   
Multi-organ failure  1  1/3 (33.33%) 
Infections and infestations   
Myelitis  1  1/3 (33.33%) 
Metabolism and nutrition disorders   
Acidosis  1  1/3 (33.33%) 
Nervous system disorders   
Nervous system disorders - Other, specify  1  1/3 (33.33%) 
Renal and urinary disorders   
Renal and urinary disorders - Other, specify  1  1/3 (33.33%) 
Reproductive system and breast disorders   
Hypoxia  1  2/3 (66.67%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage  1  2/3 (66.67%) 
Vascular disorders   
Hypotension  1  1/3 (33.33%) 
1
Term from vocabulary, CTC-4.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regimen 2
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  2/3 (66.67%) 
Investigations   
Lymphocyte count decreased  1  3/3 (100.00%) 
Platelet count decreased  1  3/3 (100.00%) 
White blood cell decreased  1  3/3 (100.00%) 
Neutrophil count decreased  1  2/3 (66.67%) 
Activated partial thromboplastin time prolonged  1  1/3 (33.33%) 
Lipase increased  1  1/3 (33.33%) 
Serum amylase increased  1  1/3 (33.33%) 
Metabolism and nutrition disorders   
Hypokalemia  1  2/3 (66.67%) 
Hyperglycemia  1  1/3 (33.33%) 
Hyperkalemia  1  1/3 (33.33%) 
Hypocalcemia  1  1/3 (33.33%) 
Hypophosphatemia  1  1/3 (33.33%) 
1
Term from vocabulary, CTC-4.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard O'Reilly, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-2157
EMail: oreillyr@mskcc.org
Layout table for additonal information
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: August 9, 2018