T-cell Depleted Alternative Donor Transplantation
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|ClinicalTrials.gov Identifier: NCT00968864|
Recruitment Status : Terminated (Sponsor/ PI leaving institution, no plans to continue this research at this time)
First Posted : August 31, 2009
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an alternative (unrelated and mismatched related) donor. The secondary objectives include evaluation of engraftment, immune recovery, and post-transplant infections.
Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant disease will be included in the study. The recipients will be grouped into one of two groups based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The patient will receive a conditioning regimen including chemotherapy drugs and/or total body irradiation based on the disease for which the transplant is performed.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Myeloid Leukemia Myelodysplastic Syndrome Lymphomas Bone Marrow Failure Hemoglobinopathy Immune Deficiency Osteopetrosis||Device: CliniMACS® (T cell depletion)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: CliniMACS® (T cell depletion)
Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.
Device: CliniMACS® (T cell depletion)
Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells.
- Number of Participants With Severe Graft vs. Host Disease (GVHD). [ Time Frame: Within 30 days after stem cell transplant ]Severe GVHD defined as grade III/IV GVHD.
- Number of Participants With Engraftment and Time to Engraftment [ Time Frame: Within 28 days after stem cell transplant ]Engraftment was measured as time to absolute neutrophil count >500
- Number of Participants With Post-transplant Infections [ Time Frame: 1 year ]
- Number of Participants With EBV-related Post Transplant Lymphoproliferative Disorder (PTLD) [ Time Frame: 5 years ]
- Number of Participants With Post-transplant Leukemia Relapse [ Time Frame: 5 years ]
- Number of Participants With Transplant-related Mortality [ Time Frame: 2 year ]Transplant-related mortality includes death due to regimen-related toxicity or GVHD (all causes other than disease relapse). Those who died due to disease relapse are not included in the analyzed population for that time point.
- Number of Participants With Transplant-related Toxicities [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 2 years ]
- Device Performance: Dose of CD34+ Cells and CD3+ Cells Given [ Time Frame: Length of the trial (5 years) ]
For mismatched related donors, the target cell dose after processing is >/= 20 x 10^6 CD34+ cells/kg patient body weight, but >/= 8 x 10^6 is acceptable.
For unrelated donors the target cell dose after processing is >/= 10 x 10^6 CD34+ cells/kg patient body weight, but >/= 4 x 10^6 is acceptable.
The target T cell dose is </= 3 x 10^4 CD3+ cells/ kg.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968864
|United States, North Carolina|
|Levine Children's Hospital, Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||Andrew Gilman, MD||Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System|