Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

NCT02294552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-01-16

No results posted yet for this study

Summary

This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in patients with different risk of GVHD. The risk-adapted strategy involves using single-agent cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem cells and mismatched bone marrow.

Conditions

Interventions

DRUG

Busulfan

DRUG

Fludarabine monophosphate

DRUG

Tacrolimus

DRUG

Mycophenolate mofetil

PROCEDURE

Allogeneic hematopoietic stem cell transplantation

Sponsors & Collaborators

  • Ivan S Moiseev

    lead OTHER

Principal Investigators

  • Boris V Afanasyev, MD, Prof. · First Pavlov State Medical University of St. Petersburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-11-30
Completion
2017-11-30

Countries

  • Russia

Study Locations

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Entities

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 NCT02294552 on ClinicalTrials.gov