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A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative

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ClinicalTrials.gov Identifier: NCT00429143
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : May 31, 2013
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hematologic Malignancies
Interventions: Radiation: Total Body Irradiation (TBI)
Biological: Donor Lymphocyte Infusion (DLI)
Drug: Cyclophosphamide (CY)
Drug: Tacrolimus
Drug: Mycophenolate Mofetil (MMF)
Biological: Hematopoietic Stem Cell Transplant (HSCT)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients presenting to Thomas Jefferson University with hematological malignancies requiring hematopoeitic stem cell transplantation without matched related donors. Opened January, 2006 through August, 2009

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
Haploidentical Allogeneic Transplantation Patients undergoing hematopoietic stem cell transplant from a partially matched related donor

Participant Flow:   Overall Study
    Haploidentical Allogeneic Transplantation
STARTED   27 
COMPLETED   27 
NOT COMPLETED   0 



  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
Haploidentical Allogeneic Transplantation Patients undergoing hematopoietic stem cell transplant from a partially matched related donor

Baseline Measures
   Haploidentical Allogeneic Transplantation 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   24 
>=65 years   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (12.9) 
Gender 
[Units: Participants]
 
Female   16 
Male   11 
Region of Enrollment 
[Units: Participants]
 
United States   27 


  Outcome Measures

1.  Primary:   Overall Survival of Participants   [ Time Frame: 6 months ]

2.  Primary:   Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD   [ Time Frame: 6 months ]

3.  Secondary:   Engraftment Rates   [ Time Frame: 6 months ]

4.  Secondary:   Lymphoid Recovery   [ Time Frame: 6 months ]

5.  Secondary:   Incidence of Grades III-IV GVHD   [ Time Frame: 6 months ]


  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
Limitations of the trial include small sample size and single institution


  More Information

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


Results Point of Contact:  
Name/Title: Neal Flomenberg, MD
Organization: Thomas Jefferson University
phone: 215-955-4367
e-mail: neal.flomenberg@jefferson.edu


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

Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00429143     History of Changes
Other Study ID Numbers: 06U.20
2005-84 ( Other Identifier: CCRRC )
First Submitted: January 29, 2007
First Posted: January 31, 2007
Results First Submitted: June 4, 2012
Results First Posted: May 31, 2013
Last Update Posted: November 29, 2016