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Study of SA+X in the Treatment of Newly Diagnosed AML

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

This is a phase II, open-label, multi-center study evaluating the efficacy and safety of sonrotoclax (SA) in combination with azacitidine (AZA) plus individualized targeted or chemotherapeutic agents in adult participants with newly diagnosed acute myeloid leukemia (AML). Eligible participants will be stratified into different treatment arms based on genetic background (FLT3/IDH1 mutation status) and fitness for intensive chemotherapy. All participants will receive sonrotoclax with dose escalation from 20 mg/day to 320 mg/day, followed by maintenance dosing, which may be temporarily held by the investigator from Day 14 to Day 28 of each 28-day cycle based on the participant's condition, combined with azacitidine 75 mg/m²/day intravenously on Days 1-7. For participants fit for intensive chemotherapy, additional anthracycline (daunorubicin 60 mg/m²/day or idarubicin 10 mg/m²/day on Days 1-3) will be administered. For participants with FLT3 mutations, gilteritinib 80 mg once daily on Days 1-14 will be added; for those with IDH1 mutations, ivosidenib 500 mg once daily on Days 1-28 will be added.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping (5th edition WHO diagnostic criteria)

Subjects with APL excluded according to fusion gene and chromosome results

ECOG performance status 0-3

Age ≥ 18 years

Disqualifiers

FAB classification as M3, or molecularly confirmed APL

Refractory / relapsed subjects

Subjects with a history of myeloproliferative neoplasms (MPN);

Subjects with a history of myelodysplastic syndromes (MDS);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anthracycline

    Drug

    For FLT3/IDH1 wild-type participants who are eligible for chemotherapy, Anthracycline: Daunorubicin (DNR) 45 mg/m² per day on Days 1-3, or Idarubicin (IDA) 6 mg/m² per day on Days 1-3.

  • Ivosidenib

    Drug

    For IDH1 mutant participants, IDH1 inhibitor (IDH1i): Ivosidenib 500 mg once daily on Days 1-28.

  • Gilteritinib

    Drug

    For FLT3 mutant participants, FLT3 inhibitor (FLT3i): Gilteritinib 80 mg once daily on Days 1-14.

  • Sonrotoclax

    Drug

    For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on Days 5-28 of a 28-day cycle; the administration of SON may be temporarily held by the investigator from Day 14 to Day 28 based on the participant's condition.

  • Azacitidine (AZA)

    Drug

    For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.

Treatment groups

205 Participants
are divided into 4 treatment groups
Group A: SA+AnthracyclineExperimental treatment 3 interventions
Group B: SA+FLT3 inhibitorExperimental treatment 3 interventions
Group C: SA+IDH1 inhibitorExperimental treatment 3 interventions
Group D: SAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Composite Complete Remission

Time frame
At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).

Secondary outcomes

1

Minimal Residual Disease (MRD) Negativity Rate

Time frame
At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
2

Overall Response Rate

Time frame
At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
3

Overall Survival

Time frame
Time from enrollment to all-cause death within 3 years
4

Event-free Survival

Time frame
Time from enrollment to treatment failure, relapse, or death from any cause within 3 years

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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