Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

Conditions

Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immune System Diseases

Keywords

Cyclophosphamide, Leukemia, Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immunosuppressive Agents, Immune System Diseases, Busulfan, Fludarabine, Tacrolimus, Mycophenolate mofetil, Antineoplastic Agents, Alkylating, Myeloablative Agonists, Hematopoietic Stem Cell Transplantation, Allogeneic

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.

Moiseev IS, Babenko EV, Epifanovskaya OS, Sergeev VS, Dotcenko AA, Bakin EA, Surkova EA, Kuznetsova DA, Lapin SV, Pirogova OV, Alyanskii AL, Golovacheva AA, Darskaya EI, Morozova EV, Markova IV, Bondarenko SN, Afanasyev BV.

2019-09-207 citations

10.1038/s41409-019-0665-3

Risk‐adapted <scp>GVHD</scp> prophylaxis with post‐transplantation cyclophosphamide in adults after related, unrelated, and haploidentical transplantations

Ivan Moiseev, Olga V. Pirogova, Alexandr L. Alyanski, Elena V. Babenko, Tatiana Gindina et al. (12 authors)

European Journal Of Haematology2018-01-2325 citations

10.1111/ejh.13030

Prevention of Acute Graft-Versus-Host Reaction after Allogeneic Unrelated Hematopoietic Stem Cell Transplantation: Comparison of Effectiveness of Treatment Regimens Based on Anti-Thymocyte Globulin and Cyclophosphamide

Olga V. Pirogova, Ivan Moiseev, E. V. Babenko, О. А. Слесарчук, О. В. Паина et al. (9 authors)

Clinical oncohematology2016-10-011 citations

10.21320/2500-2139-2016-9-4-391-397

Graft-versus-Host Disease Prophylaxis in Unrelated Peripheral Blood Stem Cell Transplantation with Post-Transplantation Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil

Ivan Moiseev, Olga V. Pirogova, Alexandr L. Alyanski, Elena V. Babenko, Tatiana Gindina et al. (9 authors)

Biology of Blood and Marrow Transplantation2016-03-09114 citations

10.1016/j.bbmt.2016.03.004

Interventions

DRUGCyclophosphamide

DRUGBusulfan

DRUGFludarabine monophosphate

DRUGTacrolimus

DRUGMycophenolate mofetil

PROCEDUREAllogeneic hematopoietic stem cell transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Incidence of acute and chronic GVHD, requiring treatment	365 days

Secondary

Measure	Time frame
Non-relapse mortality analysis	365 days
Overall survival analysis	365 days
Event-free survival analysis	365 days
Incidence of primary graft failure	60 days
Toxicity based NCI CTC grades	100 days
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence	100 days
Relapse rate analysis	365 days

Countries

Russia

Outcome results

None listed