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

ConditionsAMLRefractoryRelapsed
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Concurrent malignant tumors of other organs (patients requiring treatment).

Participants considered unsuitable for inclusion by the researchers.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

458 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Arm 1Experimental treatment 3 interventions
Group B: Arm 2Experimental treatment 3 interventions
Group C: Arm 3Experimental treatment 3 interventions
Group D: Arm 4Experimental treatment 3 interventions
Group E: Arm 5Experimental treatment 2 interventions
Group F: Arm 6Experimental treatment 1 intervention
Group G: Arm 7Experimental treatment 4 interventions
Group H: Arm 8Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
up to 4 years

Secondary outcomes

1

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

Mortality of patients treated within 30 and 60 days

Time frame
Treatment within 30 days and 60 days
2

MRD-negative complete response rate

Proportion of patients with complete response and MRD negative

Time frame
the whole period of the trial, up to 730 days
3

Overall survival

Used to evaluate all patients entering clinical trials

Time frame
the whole period of the trial, up to 730 days
4

Event-free survival

It is only used to evaluate patients who have achieved CR

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

Other outcomes

Sponsors and contacts

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

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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