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TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors

NCT03615144 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-03-24

Study results available
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Summary

The purpose of this study is to find out if removing a specific type of white blood cell (called alpha beta T-cell) that help make up the transplant donor's stem cells can improve results of blood stem cell transplant for the participant's disease.

Conditions

  • Non-Malignant Hematologic Disorders

Interventions

DRUG

Melphalan

Melphalan 70 mg/m2/day x 2

DRUG

Thiotepa

Thiotepa 7.5 mg/kg/day x 2

DRUG

Clofarabine

Clofarabine 20-30 mg/m2/day x 5

DRUG

Fludarabine

Fludarabine 30 mg/m2/day x 5

DRUG

Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®)

antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.

PROCEDURE

CliniMACS reagents

Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS.

Sponsors & Collaborators

Principal Investigators

  • Maria Cancio, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2020-11-13
Completion
2020-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03615144 on ClinicalTrials.gov