Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-75
SponsorChinese PLA General Hospital
About this trial
This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1) Acute myeloid leukemia with indications for allogeneic hematopoietic stem cell transplantation, CR1 2) Have HLA-matched sibling donors or haploidentical donors or ≥8/10 HLA-matched unrelated donors 3) The patients' ages range from 12 to 64 years old 4) Liver function: ALT and AST≤2.5 times the upper limit of normal values, bilirubin ≤2 times the upper limit of normal values 5) Renal function: Creatinine ≤ the upper limit of the normal value 6) There are no uncontrollable infections or serious mental and psychological disorders 7) Sign the informed consent form.
Disqualifiers
1. Patients with acute promyelocytic leukemia (M3) 2. One of the donor and recipient is pregnant 3. Suffering from mental illness or other conditions that prevent one from following the plan.
Trial design
Design model
Parallel
Treatments tested in this trial
Ruxolitinib, Decitabine
Combination product1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib: * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Assigned InterventionsActive comparator 1 intervention
Group B: The control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
GRFS
GVHD-free, relapse-free survival (GRFS) was defined as a composite endpoint of death from any cause, disease relapse, grade Ⅲ-Ⅳ acute GVHD, or chronic GVHD requiring systemic immunosuppression therapy.
Time frame
1 yearSecondary outcomes
1
Cumulative recurrence rate (CIR)
Calculated from the first day after stem cell infusion to the last follow-up, the number of patients with hematological or MRD recurrence/the total number of cases ×100%. The definition of hematological recurrence: After remission, patients present with one of the following three conditions: (1) ≥5% of primary lymphocytes and immature lymphocytes in the bone marrow; (2) Extramedullary leukemia occurs; (3) Leukemia cells were found in peripheral blood smears. The definition of MRD recurrence: Leukemia cells are detected by flow cytometry or molecular biology.
Time frame
1 years after transplantation2
Progression-Free Survival（PFS）
The time from the date of transplantation to the recurrence of leukemia or death for any reason.
Time frame
1 years after transplantation3
CR rate
The proportion of bone marrow in complete remission from the first day after stem cell infusion to +30 days.
Time frame
30 days after transplantation4
The incidence of aGVHD
Calculated from the first day after stem cell infusion, the time from the occurrence of aGVHD, the time of recurrence or death. The actual incidence rate is the number of patients who occur/the total number of cases ×100%.
Time frame
100 days after transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese PLA General Hospital
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Peking University People's Hospital
Collaborator
Source ClinicalTrials.gov