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Trial record 57 of 73 for:    "Paroxysmal Nocturnal Hemoglobinuria"

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
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transplant Patients
Hide Arm/Group Description 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
Period Title: Overall Study
Started 129
Completed 120
Not Completed 9
Reason Not Completed
Patient not treated             9
Arm/Group Title Transplant Patients
Hide Arm/Group Description 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
Overall Number of Baseline Participants 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
<=18 years
2
   1.6%
Between 18 and 65 years
127
  98.4%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
Female
51
  39.5%
Male
78
  60.5%
1.Primary Outcome
Title Overall Survival of Transplant Patients
Hide Description Calculate the median overall survival of transplant patients
Time Frame up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Patients
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 120
Median (Full Range)
Unit of Measure: Days
727.5
(12 to 2231)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplant Patients
Hide Arm/Group Description 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
All-Cause Mortality
Transplant Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transplant Patients
Affected / at Risk (%) # Events
Total   13/129 (10.08%)    
Blood and lymphatic system disorders   
Hemorrhage, other  1  1/129 (0.78%)  1
Cardiac disorders   
Left ventricular failure  1  1/129 (0.78%)  1
Eye disorders   
Vision-double vision  1  1/129 (0.78%)  1
General disorders   
Constitutional symptoms, other  1  4/129 (3.10%)  4
Infections and infestations   
infection unknown absolut neutriphil counts  1  1/129 (0.78%)  1
Infection without neutropenia  1  3/129 (2.33%)  3
Musculoskeletal and connective tissue disorders   
Hypoxia  1  3/129 (2.33%)  3
Nervous system disorders   
Leukoencephalopathy  1  1/129 (0.78%)  1
Seizure  1  1/129 (0.78%)  2
Renal and urinary disorders   
Renal failure  1  1/129 (0.78%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory disorder  1  1/129 (0.78%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/129 (0.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transplant Patients
Affected / at Risk (%) # Events
Total   126/129 (97.67%)    
Blood and lymphatic system disorders   
Hemoglobin (Hgb)  1  117/129 (90.70%)  117
Leukocytes  1  125/129 (96.90%)  125
Lymphopenia  1  125/129 (96.90%)  125
Neutrophils  1  123/129 (95.35%)  123
Platelets  1  124/129 (96.12%)  124
Prothrombin time (PT)  1  11/129 (8.53%)  11
Partial thromboplastin time (PTT)  1  22/129 (17.05%)  22
SGOT (AST)  1  28/129 (21.71%)  28
SGPT (ALT)  1  42/129 (32.56%)  42
Metabolism and nutrition disorders   
Alkaline phosphatase  1  23/129 (17.83%)  23
Bilirubin  1  31/129 (24.03%)  31
Creatinine  1  13/129 (10.08%)  13
Hyperglycemia  1  58/129 (44.96%)  58
Hyperkalemia  1  26/129 (20.16%)  26
Hypocalcemia  1  35/129 (27.13%)  35
Hypokalemia  1  60/129 (46.51%)  60
Hyponatremia  1  35/129 (27.13%)  35
Hypophosphatemia  1  48/129 (37.21%)  48
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
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
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