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Completed

NCT Number: NCT02294552

Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

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.

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Key information

Conditions

Acute Myeloid Leukemia Acute Lymphoid Leukemia Bone Marrow Diseases Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

busulfan

Drug

Fludarabine monophosphate

Drug

Tacrolimus

Drug

Mycophenolate mofetil

Drug

allogeneic hematopoietic stem cell transplantation

Procedure

Primary outcomes

  1. Incidence of acute and chronic GVHD, requiring treatment

    Time frame: 365 days

Secondary outcomes

  1. Incidence of primary graft failure

    Time frame: 60 days

  2. Non-relapse mortality analysis

    Time frame: 365 days

  3. Overall survival analysis

    Time frame: 365 days

  4. Event-free survival analysis

    Time frame: 365 days

  5. Relapse rate analysis

    Time frame: 365 days

  6. Toxicity based NCI CTC grades

    Time frame: 100 days

  7. Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence

    Time frame: 100 days

Sponsors and collaborators

Lead sponsor

Ivan S Moiseev

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 19, 2014
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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