TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma
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|ClinicalTrials.gov Identifier: NCT02652468|
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : March 8, 2018
To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using HLA haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma.
Assess incidence of acute GVHD (Graft versus Host Disease), chronic GVHD, graft failure rate, treatment related mortality rate, progression free survival and overall survival of patients.
The stem cell product will be processed using an investigational Miltenyi cell selection device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that are more likely to cause GVHD.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Fludarabine Phosphate Drug: Mesna Drug: Cyclophosphamide Radiation: Total nodal irradiation Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Procedure: Peripheral Blood Stem Cell Transplantation Drug: Mycophenolate Mofetil Drug: Tacrolimus Biological: Rituximab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation in Patients With Relapsed Lymphoma|
|Actual Study Start Date :||March 10, 2016|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: Peripheral Blood Stem Cell Transplant
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over approximately 30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Patients also undergo total nodal irradiation on day -1.
TRANSPLANT: Patients undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, patients may receive a second graft on day 1.
GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient).
Drug: Fludarabine Phosphate
Fludarabine will be administered by IV over approximately 30 minutes for 4 days.Drug: Mesna
Given IV over 24 hours starting prior to cyclophosphamideDrug: Cyclophosphamide
Given IV for 2 daysRadiation: Total nodal irradiation
Undergo total lymphoid irradiationBiological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplantProcedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Other Names:Procedure: Peripheral Blood Stem Cell Transplantation
Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplantDrug: Mycophenolate Mofetil
Other Name: MMFDrug: Tacrolimus
Given PO or IV ONLY if graft cell content is over 1 x 10^5 cells/kg ideal BW of the patientBiological: Rituximab
Given IV ONLY if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient
- Rate of engraftment, as defined as absolute neutrophil count >= 500/mcl for 3 consecutive measurements on different days and platelet count > 20,000/mm^3 with no platelet transfusions in the preceding 7 days [ Time Frame: At day 28 after transplantation ]To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using HLA haploidentical donors for stem cell transplant in relapsed lymphoma. Will be obtained from the Kaplan-Meier (KM) estimates along with 95% confidence intervals.
- Incidence of grade III-IV acute GVHD as determined by IBMTR Severity Index criteria [ Time Frame: Day +100 ]The cumulative incidence of grade III - IV acute GVHD by Day +100 will be determined. Will be analyzed using KM method. Acute GVHD will be obtained from t he KM estimates along with 95% confidence intervals.
- Incidence of chronic GVHD [ Time Frame: Day +180 ]The cumulative incidence of severe chronic GVHD by Day +180 will be recorded. Will be analyzed using KM method. Chronic GVHD will be obtained from the KM estimates along with 95% confidence intervals.
- Incidence of graft failure [ Time Frame: Up to 1 year after graft ]Graft failure - defined as < 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved. Will be analyzed using KM method.
- Treatment-related mortality [ Time Frame: Up to 1 year after graft ]Time to treatment-related mortality - defined as death from any cause other than disease progression - will be analyzed using KM method
- Progression-free survival [ Time Frame: Time before any progression by either PET/CT or bone marrow, assessed up to 1 year ]Progression-free survival will be analyzed using KM method.
- Overall survival (OS) [ Time Frame: Up to 1 year ]OS will be obtained from the KM estimates along with 95% confidence intervals.
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): NCT02652468
|Contact: Cancer Connectemail@example.com|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Contact: Cancer Center 800-622-8922 firstname.lastname@example.org|
|Contact: Vaishalee Kenkre 608-263-1699 email@example.com|
|Principal Investigator:||Vaishalee P Kenkre||Principal Investigator|