AML, Refractory, Relapsed
Conditions
Keywords
AML, Refractory, Relapsed
Brief summary
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
Interventions
DRUGIvosidenib
in arm 1
DRUGVenetoclax
in arms 2-5
DRUGGilteritinib
in arm 2
in arms 4 and 7
DRUGCytarabine
in arms 3 and 7
DRUGDaunorubicin/ Idarubicin /Mitoxantrone
in arms 3 and 7
DRUGAzacitidine
in arms 1，2 , 5 and 8
DRUGLisaftoclax
in arms 7 and 8
DRUGPI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others
in arm 6
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria). 2\. Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia. 3\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Exclusion criteria
1. Concurrent malignant tumors of other organs (patients requiring treatment). 2. Participants considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complex response (CRc) rate (including CR and CRi) | up to 4 years | Proportion of patients with combined responses (complete and partial responses) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality associated with salvage treatment (30 days, 60 days) | Treatment within 30 days and 60 days | Mortality of patients treated within 30 and 60 days |
| MRD-negative complete response rate | the whole period of the trial, up to 730 days | Proportion of patients with complete response and MRD negative |
| Overall survival | the whole period of the trial, up to 730 days | Used to evaluate all patients entering clinical trials |
| Event-free survival | the whole period of the trial, up to 730 days | It is only used to evaluate patients who have achieved CR |
| Relapse-free survival | the whole period of the trial, up to 730 days. | It is only used to evaluate patients who have achieved CR |
Countries
China
Outcome results
None listed