Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

Lymphoma Clinical Trial

Official title:

High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294552
• Other study ID #: PTCy-2014
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2014
• Last updated: January 12, 2018
• Start date: October 2014
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Immune System Diseases
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Lymphoma
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Drug:
• Cyclophosphamide

• Busulfan

• Fludarabine monophosphate

• Tacrolimus

• Mycophenolate mofetil

Procedure:
• Allogeneic hematopoietic stem cell transplantation

Locations

Country	Name	City	State
Russian Federation	First Pavlov State Medical University of St. Petersburg	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Ivan S Moiseev

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute and chronic GVHD, requiring treatment		365 days
Secondary	Incidence of primary graft failure		60 days
Secondary	Non-relapse mortality analysis		365 days
Secondary	Overall survival analysis		365 days
Secondary	Event-free survival analysis		365 days
Secondary	Relapse rate analysis		365 days
Secondary	Toxicity based NCI CTC grades		100 days
Secondary	Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence		100 days