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NCT Number: NCT06265545

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

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.

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Key information

Conditions

AML Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Refractory Relapsed

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.
  • 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

  • Concurrent malignant tumors of other organs (patients requiring treatment).
  • Participants considered unsuitable for inclusion by the researchers.

Treatment and study plan

Ivosidenib

Drug

in arm 1

Venetoclax

Drug

in arms 2-5

Gilteritinib

Drug

in arm 2

Homoharringtonine

Drug

in arms 4 and 7

Cytarabine

Drug

in arms 3 and 7

Daunorubicin/ Idarubicin /Mitoxantrone

Drug

in arms 3 and 7

Azacitidine

Drug

in arms 1，2 , 5 and 8

Lisaftoclax

Drug

in arms 7 and 8

PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others

Drug

in arm 6

Primary outcomes

  1. Complex response (CRc) rate (including CR and CRi)

    Time frame: up to 4 years

    Proportion of patients with combined responses (complete and partial responses)

Secondary outcomes

  1. mortality associated with salvage treatment (30 days, 60 days)

    Time frame: Treatment within 30 days and 60 days

    Mortality of patients treated within 30 and 60 days

  2. MRD-negative complete response rate

    Time frame: the whole period of the trial, up to 730 days

    Proportion of patients with complete response and MRD negative

  3. Overall survival

    Time frame: the whole period of the trial, up to 730 days

    Used to evaluate all patients entering clinical trials

  4. Event-free survival

    Time frame: the whole period of the trial, up to 730 days

    It is only used to evaluate patients who have achieved CR

  5. Relapse-free survival

    Time frame: the whole period of the trial, up to 730 days.

    It is only used to evaluate patients who have achieved CR

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2024
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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