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HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies

NCT01119066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2022-08-05

Study results available
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Summary

The purpose of this study is to find out the effects of using a system called CliniMACS to remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food and Drug Administration (FDA) has not yet approved it.

Conditions

Interventions

RADIATION

total body irradiation

dose of 1375-1500 cGy

DRUG

Thiotepa

5 mg/kg/day x 2 or 10 mg/kg/day x 1

DRUG

Cyclophosphamide

60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).

DRUG

Busulfan

0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics

DRUG

Melphalan

70mg/m2/day x 2

DRUG

Fludarabine

25mg/m2/ day x 5

DRUG

Clofarabine

20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)

PROCEDURE

(CliniMACS) T-cell depleted PBSC Transplant

Sponsors & Collaborators

Principal Investigators

  • Richard O'Reilly, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-03
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT01119066 on ClinicalTrials.gov