NCT06754540Not yet recruitingPhase 2
Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.
Efficacy and Safety of Azacitidine Combined with Donor Lymphocyte Infusion for Prevention of Recurrence After Haploid Hematopoietic Stem Cell Transplantation in High-risk Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML. At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 29 Dec 2024
- Start date
- 16 Jan 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06754540
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 51
- From 16 Jan 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Possible subjects who meet any of the following criteria will be excluded from the trial:
- Those who are allergic to known azacitidine or interferon
- Patients with active acute GVHD;
- Patients with moderate or more chronic GVHD;
- Non-haploid donor transplants;
- Patients who have not achieved complete remission after transplantation;
- AML recurrence after transplantation (bone marrow, peripheral blood primitive cells ≥5% or extramedullary recurrence), or graft rejection, bone marrow donor cell chimeric rate (STR) \<90%;
- Patient blood routine: ANC\<1.0×10\^9/L or PLT\<50×10\^9/L;
- Combined with severe organ dysfunction:liver function (AST/ALT) \>3 times normal upper limit; the direct bilirubin \> 3 times normal upper limit; renal function (Cr) \< 50mL/min or \>1.5 times normal upper limit, regardless of hemodialysis treatment;
- Patient with severe active infection;
- Pregnant or lactating women;
- Have received other interventions or are receiving other research drugs before the study begins;
- At the discretion of the investigator, other dangerous complications may result.
Who the study is looking for
- \-
- Patients enrolled must meet the following criteria:
- ≥18 years old and ≤70 years old, male or female;
- Patients with haploid peripheral blood stem cell transplantation of AML;
- All patients received BU based myeloablative conditionings;
- A diagnosis of high-risk AML is one of the following:
- ① Patients without morphologic CR before transplantation, including patients with initial refractory disease and recurrence.
- ② AML with poor prognosis (Standardized diagnosis and prognostic stratification of acute myeloid leukemia based on ELN edition which was 2022 Year) .
- Blood routine: neutrophils ≥1×10\^9/L, platelet ≥50.0×10\^9/L;
- There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;
- The ECOG score is 0 to 2;
- Donor lymphocytes are available;
- The patient must be able to understand and be willing to participate in the study and sign an informed consent form.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.