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

NCT02652468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-01-05

Study results available
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Summary

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.

Conditions

Interventions

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 cyclophosphamide

DRUG

Cyclophosphamide

Given IV for 2 days

RADIATION

Total nodal irradiation

Undergo total lymphoid irradiation

BIOLOGICAL

T Cell-Depleted Hematopoietic Stem Cell Transplantation

Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant

DRUG

Mycophenolate Mofetil

Given PO

DRUG

Tacrolimus

Given PO or IV ONLY if graft cell content is over 1 x 10\^5 cells/kg ideal BW of the patient

BIOLOGICAL

Rituximab

Given IV ONLY if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Vaishalee P Kenkre · Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2018-09-01
Completion
2021-09-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652468 on ClinicalTrials.gov