Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
NCT02294552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2018-01-16
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
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Chronic Lymphocytic Leukemia
- Immune System Diseases
Interventions
- DRUG
- DRUG
-
Busulfan
- DRUG
-
Fludarabine monophosphate
- DRUG
- 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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