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T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases

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ClinicalTrials.gov Identifier: NCT00589602
Recruitment Status : Terminated (slow accrual)
First Posted : January 9, 2008
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jaroslaw Maciejewski, The Cleveland Clinic

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Malignant Plasma Cell Neoplasms
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Secondary Myelofibrosis
Interventions: Procedure: peripheral blood lymphocyte therapy
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation (TBI)

  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 were recruited from local hospital from January, 2006 through January, 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
T-Cell Depletion Transplant

Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.

Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'

peripheral blood lymphocyte therapy: T-cell depletion

cyclophosphamide: T-cell depletion

tacrolimus: T-cell depletion

allogeneic hematopoietic stem cell transplantation: T-cell depletion

peripheral blood stem cell transplantation: T-cell depletion

total-body irradiation: T-cell depletion

Participant Flow:   Overall Study
    T-Cell Depletion Transplant
STARTED   13 
COMPLETED   12 
NOT COMPLETED   1 
Did not collect enough CD34+ cells                1 



  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
T-Cell Depletion Transplant

Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.

Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'

peripheral blood lymphocyte therapy: T-cell depletion

cyclophosphamide: T-cell depletion

tacrolimus: T-cell depletion

allogeneic hematopoietic stem cell transplantation: T-cell depletion

peripheral blood stem cell transplantation: T-cell depletion

total-body irradiation: T-cell depletion

Baseline Measures
   T-Cell Depletion Transplant 
Overall Participants Analyzed 
[Units: Participants]
 		 13 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      1   7.7% 
Between 18 and 65 years      12  92.3% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range) 		 46 
 (18 to 58) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      7  53.8% 
Male      6  46.2% 
Region of Enrollment 
[Units: Participants]
 		 
United States   13 


  Outcome Measures

1.  Primary:   Treatment-related Mortality (TRM)   [ Time Frame: 180 days after transplant ]
  Show Outcome Measure 1

2.  Secondary:   The Rate of Acute Graft Versus Host Disease (GVHD)   [ Time Frame: D+100 from transplant ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Duration of Absolute Neutropenia   [ Time Frame: D+100 from transplant ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants Able to Receive T-cell Add Backs   [ Time Frame: through D+100 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Relapse-free Survival   [ Time Frame: after 7 years of follow up ]
  Show Outcome Measure 5


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jarek Maciejewski, MD
Organization: Cleveland Clinic
phone: 216-445-5962
e-mail: maciejj@ccf.org



Responsible Party: Jaroslaw Maciejewski, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589602     History of Changes
Other Study ID Numbers: CCF-6501
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: January 1, 2008
First Posted: January 9, 2008
Results First Submitted: September 20, 2016
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017