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UNKNOWNPHASE1/PHASE2

Ruxolitinib and Decitabine for High Risk Hematological Malignancies

Ruxolitinib and Decitabine Intensified Conditioning Regimen for Patients With High Risk Hematological Malignancies Underwenting Allogeneic Stem Cell Transplantation

NCT04582604•Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Decitabine intensified Conditioning Regimen in Patients with High Risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Detailed Description

Allogeneic hematopoietic stem cell transplantation should be offered to eligible patients with high risk hematological malignancies whenever feasible. To further improve the outcome of transplantation patients with high risk hematological malignancies, the investigators developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine. In this study, the investigators tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine in Patients with high risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility

Age

12 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Relapsed/refractory acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; High risk acute leukemia with indications for allogeneic hematopoietic stem cell transplantation;
•2. Medium to high risk myelodysplastic syndrome, myeloproliferative disease, myelodysplastic syndrome/myeloproliferative disease, Chronic myelomonocytic leukemia;
•3. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors
•4. All patients should aged 12 to 65 years;
•5. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
•6. Renal function: creatinine ≤the upper limit of normal;
•7. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
•8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
•9. Have signed informed consent.

Exclusion Criteria

•1. pregnant women;
•2. Patients with mental illness or other states unable to comply with the protocol;
•3. AML patients with t (15;17);

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 1, 2020

Primary Completion Date

September 1, 2023

Completion Date

September 30, 2025

Last Updated

October 20, 2020

Enrollment

ESTIMATED participants

Conditions

Peripheral Blood Stem Cell Transplantation

Interventions

modified By/Cy conditioning regimen intensified by Ruxolitinib and Decitabine

DRUG

Contacts

Daihong Liu

CONTACT

86-13681171597 daihongrm@163.com

Liping Dou

CONTACT

96-13681207138 lipingruirui@163.com

The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

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Peripheral Blood Stem Cell TransplantationHematopoietic Stem Cell Transplantation

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UNKNOWNPHASE1/PHASE2

Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ruxolitinib and Decitabine for High Risk Hematological Malignancies

Inclusion Criteria

Exclusion Criteria

The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

KRN125 for Mobilization of Hematopoietic Stem Cells

Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD