NCT07101588 Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial
| NCT ID | NCT07101588 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2025-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07101588 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 75 Years, studying Allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07101588 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07101588 currently recruiting?
Yes, NCT07101588 is actively recruiting participants. Contact the research team at lipingruirui@163.com for enrollment information.
Where is the NCT07101588 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07101588 clinical trial?
NCT07101588 is sponsored by Chinese PLA General Hospital. The trial plans to enroll 200 participants.