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RECRUITING

NCT06532084

PHASE2

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Sponsor: St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

Summary

This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.

Official title: Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-22

Completion Date

2028-05

Last Updated

2024-08-01

Healthy Volunteers

Conditions

Acute Myeloid Leukemia, in Relapse Myelodysplastic Syndromes Chronic Myeloid Leukemia Myeloproliferative Neoplasm

Interventions

DRUG

Sorafenib

Sorafenib 200 mg bid for 168 days starting in the time fram between engraftment with neutrophils \> 1.0 x 10\^9/L, white blood cells\> 1.5 x 10\^9/L, platelets\> 1.5 x 10\^9/L and day+100 after allogeneic hematopoietic cell trnaplantation

Inclusion Criteria: * Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor. * Patients must have high-risk myeloid malignancy as an indication for transplantation defined as: * acute myeloid leukemia not in hematological remission prior to transplantation, * ≥ 3 remission of acute myeloid leukemia, * any myeloid malignancy with bi-allelic tp53 mutation, * any myeloid malignancy with complex karyotype, * therapy-related myeloid malignancy not in MRD-negative response * myelodysplastic syndrome with very high IPSS-R risk * any myeloid malignancy with monosomal or t(3;3) karyotype, * any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression * MDS/NPM unclassified not in hematologic remission. * Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed * First 100 days after allogeneic hematopoietic stem cell transplantation Exclusion Criteria: * successfully treated relapse between transplantation and enrollment * use of any other planned method for prophylaxis of relapse besides sorafenib * donor lymphocyte infusion prior to randomization * Second malignancy not in complete remission within 6 months prior to randomization * Moderate or severe cardiac disease: ejection fraction \<50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion * Stroke within 3 months of inclusion, unless related to the underlying malignancy * Severe decrease in pulmonary function: FEV1 \<50% or DLCO\<50% of predicted or respiratory distress or need for oxygen support; * Severe organ dysfunction: AST or ALT \>10 upper normal limits, bilirubin \>2 upper normal limits, creatinine \>2 upper normal limits * Creatinine clearance \< 30 mL/min * Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\> 70 mg/L * Requirement for vasopressor support at the time of enrollment * Requirement for positive-pressure oxygen at the time of enrollment * Karnofsky index \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent

Locations (1)

RM Gorbacheva Research Institute

Saint Petersburg, Russia