Clinical trial NCT04582604: Ruxolitinib and Decitabine for High Risk Hematological Malignancies
Official title: Ruxolitinib and Decitabine Intensified Conditioning Regimen for Patients With High Risk Hematological Malignancies Underwenting Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peripheral Blood Stem Cell Transplantation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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);

Primary outcomes:
measure: Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria
timeFrame: 365 days after transplantation
Secondary outcomes:
measure: DFS(disease-free survival )
timeFrame: 365 days after transplantation
measure: TRM(treatment-related mortality )
timeFrame: 365 days after transplantation
measure: Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
timeFrame: 100 days after transplantation
measure: Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)
timeFrame: 365 days after transplantation
measure: OS(overall survival )
timeFrame: 365 days after transplantation
measure: GRFS (GVHD free, relapse free survival)
timeFrame: 365 days after transplantation
measure: infection rate
timeFrame: 365 days after transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu
role: PRINCIPAL_INVESTIGATOR
References:
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