Status:
COMPLETED
Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
Lead Sponsor:
Ivan S Moiseev
Conditions:
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 differe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02294552
Start Date
October 1 2014
End Date
November 1 2017
Last Update
January 16 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197089