Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

AML Clinical Trial

Official title:

Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265545
• Other study ID #: RR-AML-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid, Acute
• Refractory
• Relapsed

Intervention

Drug:
• Ivosidenib,Venetoclax,gilteritinib,Selinexor
if the target gene mutations are positive, enter arm1 or arm2. other conditions, enter the chemotherapy arms (Arm3-6)

Locations

Country	Name	City	State
China	Blood Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complex response (CRc) rate (including CR and CRi)	Proportion of patients with combined responses (complete and partial responses)	Time from remission date of the first subject until remission date of the last subject.
Secondary	mortality associated with salvage treatment (30 days, 60 days)	Mortality of patients treated within 30 and 60 days	Treatment within 30 days and 60 days
Secondary	MRD-negative complete response rate	Proportion of patients with complete response and MRD negative	the whole period of the trial, up to 730 days
Secondary	Overall survival	Used to evaluate all patients entering clinical trials	the whole period of the trial, up to 730 days
Secondary	Event-free survival	It is only used to evaluate patients who have achieved CR	the whole period of the trial, up to 730 days
Secondary	Relapse-free survival	It is only used to evaluate patients who have achieved CR	the whole period of the trial, up to 730 days.