Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378534
Recruitment Status : Completed
First Posted : September 20, 2006
Results First Posted : January 6, 2015
Last Update Posted : October 28, 2015
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

  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
CD34 Selection

T cell depletion

Miltenyi Clinimax CD34 Reagent System: T cell depletion

Participant Flow:   Overall Study
    CD34 Selection
STARTED   115 
COMPLETED   55 [1] 
Donors                57 
Subjects did not receive a transplant                3 
[1] Transplantation Recipients

  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
Hematologic Survival Using Miltenyi Reagent System 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.

Baseline Measures
   Hematologic Survival Using Miltenyi Reagent System 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   2 
Between 18 and 65 years   109 
>=65 years   4 
[Units: Participants]
Female   59 
Male   56 
Region of Enrollment 
[Units: Participants]
United States   115 

  Outcome Measures

1.  Primary:   Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System   [ Time Frame: Day 200 ]

2.  Secondary:   Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease.   [ Time Frame: 3 years maximum ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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: Minocher Battiwalla, MD
Organization: NIH NHLBI
phone: 301-827-0939

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Minoo Battiwalla, M.D., National Institutes of Health Clinical Center (CC) 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