ClinicalTrials.gov
ClinicalTrials.gov Menu

Mismatched Donor Lymphocyte Infusions for Relapsed Disease Following Allogeneic Stem Cell Transplantation

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.
ClinicalTrials.gov Identifier: NCT00859586
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : November 6, 2015
Last Update Posted : November 6, 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 Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Leukemia, Myelocytic, Chronic
Intervention Device: Miltenyi Magnetic cell sorter for CD3
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Miltenyi Magnetic Cell Sorter for CD3
Hide Arm/Group Description

Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.

This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.

Period Title: Overall Study
Started 8
Completed 4
Not Completed 4
Reason Not Completed
Donors             4
Arm/Group Title Miltenyi Magnetic Cell Sorter for CD3
Hide Arm/Group Description

Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.

This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
6
  75.0%
Male
2
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
4
  50.0%
Not Hispanic or Latino
4
  50.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Overall Recipient Survival at 6-month Post-relapse of Disease
Hide Description This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.
Time Frame 6 months post-relapse of disease
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Miltenyi Magnetic Cell Sorter for CD3
Hide Arm/Group Description:

Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.

This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Recipent Survival 0
Recipient Mortality 4
2.Secondary Outcome
Title Incidence and Severity Induced GvHD, Proportion of DLI Engraftment, Peak Chimerism, Leukemia Response at Days Post DLI, Residual Leukemia Measured by Patient Chimerism, Leukemia Free Survival From Date Relapse, Safety of Mismatched DLI Procedure...
Hide Description [Not Specified]
Time Frame Severity of GvHD.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Miltenyi Magnetic Cell Sorter for CD3
Hide Arm/Group Description

Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.

This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.

All-Cause Mortality
Miltenyi Magnetic Cell Sorter for CD3
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Miltenyi Magnetic Cell Sorter for CD3
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Bone marrow hypocellular *  2/4 (50.00%)  2
Disease relapse *  2/4 (50.00%)  2
Cardiac disorders   
Cardiac Arrythmia *  1/4 (25.00%)  1
General disorders   
Multi-organ failure *  2/4 (50.00%)  2
Respiratory, thoracic and mediastinal disorders   
Pulmonary Insufficiency *  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Miltenyi Magnetic Cell Sorter for CD3
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Minoo Battiwalla
Organization: NIH NHLBI
Phone: 301-827-0939
Responsible Party: Minoo Battiwalla, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00859586     History of Changes
Other Study ID Numbers: 090087
09-H-0087 ( Other Identifier: NIH NHLBI )
First Submitted: March 10, 2009
First Posted: March 11, 2009
Results First Submitted: October 5, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015