Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Blood Hospital
RECRUITING
Tianjin
Time Frame
Start Date:2024-02-22
Estimated Completion Date:2026-06-30
Participants
Target number of participants:120
Treatments
Experimental: Arm 1
With IDH1 gene mutation(up to 2 cycles available):IVA :~Ivosidenib 500mg d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax100mg d1,200mg d2,400mg d3-21 400mg ;d22-28(If the proportion of 21st bone marrow blasts is greater than 5%)
Experimental: Arm 2
FLT3/ITD or FLT3/TKD gene mutation (up to 2 cycles available)~GV :~Gilteritinib 120mg, d1-28 Venetoclax 100mg d1, 200mg d2, 400mg d3-21 400mg d22-28 (if the proportion of 21st bone marrow blasts are greater than 5%)
Experimental: Arm 3
For R/R AML patients without IDH1 or FLT3 mutations who have not been exposed to Venecra in the last 3 months, the investigators will determine whether they are fit patients based on physical status and comorbidivities, and if they are, they can be randomly assigned to Arm3 or Arm4 DAV/IAV/MAV Cytarabine 100mg/m2/d, d1-5 Daunorubicin 60mg/m2/d, d1-2, or Idarubicin 12mg/m2/d, d1-2, or mitoxantrone 8mg/m2/d d1-2 Venetoclax 100mg d3, 200mg d4, 400mg d5-11;
A patient with R/R AML without IDH1 or FLT3 mutation who has not been exposed to Venetoclax in the last 3 months but who is judged by the investigators to be unfit based on physical fitness and comorbidivities is unfit to enter Arm5.~Arm5: (up to 4 cycles available)~VA :~Azacytidine 75mg/m2/d d1-7 Venetoclax 100mg d1, 200mg d2, 400mg d3-21 400mg d22-28 (if the proportion of 21st bone marrow blasts are greater than 5%)
Experimental: Arm 6
Patients with R/R AML without IDH1 or FLT3 mutations who have been exposed to Vinecra within the last 3 months may be enrolled in the exploratory protocol group based on a comprehensive assessment of local drug availability and patient status:~Arm6:~The Investigator's choice (IC) option involves a range of drugs such as clatabine, PI3K inhibitors, histone deacetylase inhibitors, celinisol, and novel liposomes.
Experimental: Arm 7
According to the patient's condition and physical condition, evaluate whether there is a suitable new drug clinical trial to be enrolled. If there is, enter the Arm 7 (new drug clinical trial).