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
Qualifiers
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
Treatments tested in this trial
- Ruxolitinib, Decitabine
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Peking University People's Hospital
Collaborator
Source ClinicalTrials.gov