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Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation

NCT00586547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-01-21

No results posted yet for this study

Summary

This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of \< / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.

Conditions

Interventions

BIOLOGICAL

T-Cell Infusion Dose Level -1

(1 x 10\^3 T cells/Kg)

BIOLOGICAL

T-Cell Infusion Dose Level 1

(1 x 10\^4 T cells/Kg)

BIOLOGICAL

T-Cell Infusion Dose Level 2

(1 x 10\^5 T cells/Kg)

BIOLOGICAL

T-Cell Infusion Dose Level 3

(1 x 10\^6 T cells/Kg)

BIOLOGICAL

T-Cell Infusion- Dose Level 4

(5 x 10\^6 T cells/Kg)

Sponsors & Collaborators

  • University of Texas, Southwestern Medical Center at Dallas

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Malcolm Brenner, MB, PhD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00586547 on ClinicalTrials.gov