Overview

Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ivan S Moiseev
St. Petersburg State Pavlov Medical University
Treatments:
Antineoplastic Agents, Alkylating
Busulfan
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Vidarabine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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