Clinical trial NCT06265545: Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
Official title: Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AML
Refractory
Relapsed
Keywords: AML
Refractory
Relapsed
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: It is recommended to routinely screen for chromosomal karyotype, FLT3/ITD, FLT3/TKD and IDH1 mutations before enrollment.According to the patient's condition and physical condition, evaluate whether there is a suitable new drug clinical trial to enroll, if there is, enter the Arm 7 (new drug clinical trial); If not, enter other arm of the clinical study.According to the results of gene mutation, patients with target gene mutations should enter the corresponding study cohort (Arm1, Arm2), and select the regimen of specific targeted drug composition. For patients without a target mutation, patients eligible for intensive chemotherapy who had not received Venetoclax in the last 3 months were randomized to the Daunorubicin/idarbicin/mitoxantrone combination cytarabine + Venetoclax(DAV) (Arm3) and the Hyperhardinine combination cytarabine + Venetoclax cohort (HAV) (Arm4). Patients who were intolerant to intense chemotherapy were enrolled in the Venetoclax combined with Azacitidine cohort (Arm5). For patients who have failed treatment with Venetoclax within the last 3 months, the Venetoclax-based regimen is not recommended again and the physician is advised to conduct an exploratory trial (Arm6). After CR form induction therapy, allogeneic hematopoietic stem cell transplantation should be selected as far as possible according to the patient's wishes. For patients who are unable or unwilling to undergo allogeneic hematopoietic stem cell transplantation, physicians may choose post-remission consolidation therapy based on experience.

Eligibility criteria: 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.

Primary outcomes:
measure: Complex response (CRc) rate (including CR and CRi)
timeFrame: Time from remission date of the first subject until remission date of the last subject.
Secondary outcomes:
measure: mortality associated with salvage treatment (30 days, 60 days)
timeFrame: Treatment within 30 days and 60 days
measure: MRD-negative complete response rate
timeFrame: the whole period of the trial, up to 730 days
measure: Overall survival
timeFrame: the whole period of the trial, up to 730 days
measure: Event-free survival
timeFrame: the whole period of the trial, up to 730 days
measure: Relapse-free survival
timeFrame: the whole period of the trial, up to 730 days.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Blood Hospital
Study officials:
References: