Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJanuary 16, 2018
January 1, 2018
2.1 years
October 30, 2014
January 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of acute and chronic GVHD, requiring treatment
365 days
Secondary Outcomes (7)
Incidence of primary graft failure
60 days
Non-relapse mortality analysis
365 days
Overall survival analysis
365 days
Event-free survival analysis
365 days
Relapse rate analysis
365 days
- +2 more secondary outcomes
Study Arms (3)
Matched bone marrow graft
EXPERIMENTALDays -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv
Matched peripheral blood stem cells graft
EXPERIMENTALDays -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Days +5 through +35: Mycophenolate mofetil 30 mg/kg/day, maximum 2 g/day, iv or po x 30 days Days +5 through +120: Tacrolimus 0.03 mg/kg/day with further correction by concentration
Mismatched peripheral blood stem cells or bone marrow graft
EXPERIMENTALDays -8 through -4: Busulfan 1 mg/kg po qid x 4 days Days -3 through -2: Cyclophosphamide 50mg/kg/day iv x 2 days Or Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -4 through -3: Busulfan 1 mg/kg po qid x 2 days Day 0: Infusion of unmanipulated graft Day +3 and +4: Cyclophosphamide 50 mg/kg/day iv Days +5 through +35: Mycophenolate mofetil 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days Days +5 through +120: Tacrolimus 0.03 mg/kg/day with further correction by concentration
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have an indication for allogeneic hematopoietic stem cell transplantation
- Signed informed consent
- Patients with a donor available. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is required for related donor. A minimum match of 8/10 is required for unrelated donor.
- No second tumors
- No severe concurrent illness
You may not qualify if:
- Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
- Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
- Respiratory distress \>grade I
- Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
- Creatinine clearance \< 60 mL/min
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index \<30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ivan S Moiseevlead
Study Sites (1)
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089, Russia
Related Publications (1)
Moiseev IS, Pirogova OV, Alyanski AL, Babenko EV, Gindina TL, Darskaya EI, Slesarchuk OA, Bykova TA, Chukhlovin AB, Pevtcov DE, Bondarenko SN, Afanasyev BV. Risk-adapted GVHD prophylaxis with post-transplantation cyclophosphamide in adults after related, unrelated, and haploidentical transplantations. Eur J Haematol. 2018 May;100(5):395-402. doi: 10.1111/ejh.13030. Epub 2018 Mar 1.
PMID: 29360184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris V Afanasyev, MD, Prof.
First Pavlov State Medical University of St. Petersburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 19, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2017
Last Updated
January 16, 2018
Record last verified: 2018-01