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Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

NCT03852407 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2022-10-12

No results posted yet for this study

Summary

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).

Conditions

Interventions

DRUG

Thymoglobulin

ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)

DRUG

Melphalan

100mg/m² on day -2

DRUG

Fludarabine

30mg/m² on days -6, -5, -4, -3, and -2

DRUG

Cyclophosphamid

50 mg/kg on days +3 and +4.

Sponsors & Collaborators

  • Belgian Hematological Society

    collaborator OTHER

  • University of Liege

    lead OTHER

Principal Investigators

  • Frédéric Baron, MD,Ph · Centre Hospitalier Universitaire de Liege

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2033-11-01
Completion
2038-11-01

Countries

  • Belgium

Study Locations

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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 NCT03852407 on ClinicalTrials.gov