New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (NCT05029141) | Clinical Trial Compass
Active — Not RecruitingPhase 2
New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
China21 participantsStarted 2021-09-01
Plain-language summary
This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia
Who can participate
Age range18 Years – 69 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged ≥ 18 and ≤ 70 years
* Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL)
* Patients with AML must meet one of the following criteria, A or B:
A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) \< 50% and \> 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
* ECOG performance status score less than 3
* Expected survival time ˃ 3 months
* Patients without serious heart, lung, liver, or kidney disease
* Ability to understand and voluntarily provide informed consent
Exclusion Criteria:
* Patients who are allergic to the study drug or drugs with similar chemical structures
* Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
* Active infection
* Active bleeding
* Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
* Patients with mental disorders or other conditions whereby informed consent ca…
What they're measuring
1
Overall response rate (ORR)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
2
Complete remission without minimal residual disease (CR with MRD-)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
3
Complete remission with incomplete hematologic recovery (CRi)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
4
Morphologic leukemia-free state (MLFS)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
5
Partial remission (PR)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
Trial details
NCT IDNCT05029141
SponsorThe First Affiliated Hospital of Soochow University