TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT02652468
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine Phosphate — DRUG
    Fludarabine will be administered by IV over approximately 30 minutes for 4 days.
  • Mesna — DRUG
    Given IV over 24 hours starting prior to cyclophosphamide
  • Cyclophosphamide — DRUG
    Given IV for 2 days
  • Total nodal irradiation — RADIATION
    Undergo total lymphoid irradiation
  • T Cell-Depleted Hematopoietic Stem Cell Transplantation — BIOLOGICAL
    Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant
  • Mycophenolate Mofetil — DRUG
    Given PO
  • Tacrolimus — DRUG
    Given PO or IV ONLY if graft cell content is over 1 x 10\^5 cells/kg ideal BW of the patient
  • Rituximab — BIOLOGICAL
    Given IV ONLY if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient

Study Details

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma. Assess incidence of acute Graft Versus Host Disease (GVHD), 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.

Key Dates

Start date
Mar 10, 2016
Status verified
Dec 2021
Primary completion
Sep 1, 2018
Completion
Sep 17, 2021

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Peripheral Blood Stem Cell Transplant
    PREPARATIVE REGIMEN: Participants 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. Participants also undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo T-Cell Receptor (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 participant body weight (BW), patients may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (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 participant).

Primary Outcome Measure

Number of Participants With 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53705-

Find similar trials in Madison, WI

By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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