Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT

Status Terminated

Clinical Trial Summary

Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide (PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow transplantation. There is limitted, but growing data on safety and efficacy of this prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest. On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On the other hand, there is a concern, that PTCy can increase the incidence of graft failures in this group of patients. Currently published data indicate that low-dose Thymoglobulin-based prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the paramter that takes into account the most important factors effecting survival. The conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil and tacrolimus) will be identical in the two arms of the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Chronic Disease
Leukemia
Leukemia, Chronic Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplastic Syndromes
Preleukemia
Syndrome

Clinical Trial Details

NCT number	NCT02627573
Study type	Interventional
Source	St. Petersburg State Pavlov Medical University
Contact
Status	Terminated
Phase	Phase 2
Start date	July 2015
Completion date	April 3, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Terminated	`NCT04313881` - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)	Phase 3
Recruiting	`NCT05088356` - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft	Phase 1
Recruiting	`NCT04003220` - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed	`NCT02916979` - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG	Phase 1
Active, not recruiting	`NCT03755414` - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation	Phase 1
Completed	`NCT00003270` - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer	Phase 2
Recruiting	`NCT04904588` - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	Phase 2
Terminated	`NCT04866056` - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.	Phase 1/Phase 2
Recruiting	`NCT04701229` - Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
Suspended	`NCT04485065` - Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS	Phase 1
Recruiting	`NCT04174547` - An European Platform for Translational Research in Myelodysplastic Syndromes
Enrolling by invitation	`NCT04093570` - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers	Phase 2
Completed	`NCT02508870` - A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes	Phase 1
Completed	`NCT04543305` - A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies	Phase 1
Recruiting	`NCT05384691` - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions	Phase 2
Recruiting	`NCT05365035` - A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts	Phase 2
Recruiting	`NCT06008405` - Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy	Phase 1
Not yet recruiting	`NCT05969821` - Clonal Hematopoiesis of Immunological Significance
Withdrawn	`NCT05170828` - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies	Phase 1