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Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants

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ClinicalTrials.gov Identifier: NCT00378534
Recruitment Status : Completed
First Posted : September 20, 2006
Results First Posted : January 6, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Minoo Battiwalla, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myelogenous Leukemia
Acute Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Interventions Device: Miltenyi reagent system
Drug: Fludarabine
Drug: Cyclosporine
Drug: Cyclophosphamide
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CD34 Selection
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T cell depletion

Miltenyi Clinimax CD34 Reagent System: T cell depletion

Period Title: Overall Study
Started 115
Completed 55 [1]
Not Completed 60
Reason Not Completed
Donors             57
Subjects did not receive a transplant             3
[1]
Transplantation Recipients
Arm/Group Title Hematologic Survival Using Miltenyi Reagent System
Hide Arm/Group Description Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
Overall Number of Baseline Participants 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
<=18 years
2
   1.7%
Between 18 and 65 years
109
  94.8%
>=65 years
4
   3.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
Female
59
  51.3%
Male
56
  48.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 115 participants
115
1.Primary Outcome
Title Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System
Hide Description Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200.
Time Frame Day 200
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hematologic Survival Using Miltenyi Reagent System
Hide Arm/Group Description:
Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
Survival at day 200 43
Non-relapse mortality 4
2.Secondary Outcome
Title Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease.
Hide Description [Not Specified]
Time Frame 3 years maximum
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplant Recipients
Hide Arm/Group Description

T cell depletion

Miltenyi Clinimax CD34 Reagent System: T cell depletion

All-Cause Mortality
Transplant Recipients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transplant Recipients
Affected / at Risk (%) # Events
Total   14/55 (25.45%)    
Blood and lymphatic system disorders   
Graft failure *  3/55 (5.45%)  3
Hemorrhage * [1]  1/55 (1.82%)  1
Microangiopathy Anemia *  1/55 (1.82%)  1
Cardiac disorders   
Arrythmia *  1/55 (1.82%)  1
Immune system disorders   
GVHD *  4/55 (7.27%)  4
Posterior reversible encephalopathy syndrome *  1/55 (1.82%)  1
Infections and infestations   
Infection *  7/55 (12.73%)  7
Musculoskeletal and connective tissue disorders   
Hip fracture *  1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary emboli *  1/55 (1.82%)  1
Vascular disorders   
Deep vein thrombosis *  1/55 (1.82%)  1
*
Indicates events were collected by non-systematic assessment
[1]
rectal hemorrhage
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transplant Recipients
Affected / at Risk (%) # Events
Total   0/55 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Minocher Battiwalla, MD
Organization: NIH NHLBI
Phone: 301-827-0939
Responsible Party: Minoo Battiwalla, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00378534     History of Changes
Obsolete Identifiers: NCT00398346
Other Study ID Numbers: 060248
06-H-0248 ( Other Identifier: NIH National Heart, Lung and Blood Institute )
First Submitted: September 19, 2006
First Posted: September 20, 2006
Results First Submitted: December 22, 2014
Results First Posted: January 6, 2015
Last Update Posted: October 28, 2015