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Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease

ConditionAcute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYehui Tan

About this trial

A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping.

Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up.

Age ≥ 18 years.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Disqualifiers

Acute promyelocytic leukemia (APL).

Mixed phenotype acute leukemia (MPAL).

AML patients with known central nervous system (CNS) involvement.

Presence of extramedullary disease (EMD).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venetoclax

    Drug

    Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: venetoclax，8-14dExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Modified Composite Complete Response Rate（mCRc）

Complete Response（CR） + Complete Response with Incomplete Hematologic Recovery（CRi）+Morphologic Leukemia Free State（MLFS）

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Overall Survival (OS)

Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.

Time frame
From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
2

MRD Negative Conversion Rate

Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy.

Time frame
Through study completion, an average of 1 year
3

Relapse-Free Survival(RFS)

Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up

Time frame
From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yehui Tan

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
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