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Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital

About this trial

To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);

Age ≥18 years old;

ECOG≤4;

The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.

Disqualifiers

Known history of allergy to the investigational drug;

Resistance to azacytidine, azacitidine, Venetoclax;

Inability to take oral medication;

Combined with uncontrolled active infections (including bacterial, fungal or viral infections);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chidamide

    Drug

    Induction Therapy

  • Venetoclax

    Drug

    Induction Therapy

  • azacitidine

    Drug

    Induction Therapy

  • Anthracyclines or anthraquinones

    Drug

    Induction Therapy

  • cytarabine

    Drug

    Induction Therapy

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: ABC-14 regimenExperimental treatment 3 interventions
Group B: 3+7 chemotherapy regimenActive comparator 2 interventions
Group C: AB-14 regimenActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Composite complete remission (CRc)

composite complete remission，CRc: CR + CRi + MLFS

Time frame
2 months

Secondary outcomes

1

the rate of MRD turn negative

minimal residual disease turn negative

Time frame
6 months
2

DoR

Duration of remission

Time frame
2 year
3

RFS

Relapsed-free survival

Time frame
1 year
4

OS

Overall survival

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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