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Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation

NCT03600896 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-01-10

No results posted yet for this study

Summary

Participant is being asked to take part in this study because participant received an umbilical cord blood transplant as part of participant's standard treatment. Umbilical cord blood is a source of blood-forming cells that can be used for transplantation, also known as a graft.

The problem with this type of transplant is the small number of blood-forming cells available in cord blood transplants, which may delay the "take" of the graft in the transplant recipient.

There are 2 parts to this study.

The goal of Part 1 of this clinical research study is to learn if it is safe and practical to give recombinant human interleukin-7 (CYT107) to patients who have received a cord blood transplant. Researchers want to learn if CYT107 affects the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, NK cells, and B cells) in patients who have had a cord blood transplant.

The goal of Part 2 of this study is to learn if CYT107 may prevent or reduce the effects of graft-versus host disease (GVHD) or the likelihood of developing infections (such as cytomegalovirus \[CMV\], Epstein-Barr virus \[EBV\], and BK virus). GVHD happens when transplanted donor tissue attacks the tissues of the recipient's body.

This is an investigational study. CYT107 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how CYT107 is designed to work.

Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

  • Umbilical Cord Blood Transplant

Interventions

DRUG

CYT107

Phase I: Patients will be treated with CYT107 post CBT (from 60 to 180 days), in with 1 of 3 doses below: * 5 mcg/kg/dose for 3 doses * 10 mcg/kg/dose for 3 doses * 20 mcg/kg/dose for 3 doses The optimal recommended dose determined in Phase I will be used to treat all patient enrolled in Phase II.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Revimmune

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Marin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2023-11-30
Completion
2024-11-30
FDA Drug
Yes

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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 NCT03600896 on ClinicalTrials.gov