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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06265545
Other study ID # RR-AML-2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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