Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).

Age 18-65.

ECOG score: 0-2.

No history of previous chemotherapy or target therapy.

Disqualifiers

AML transformed with chronic myelogenous leukemia.

Acute promyelocytic leukemia (type M3).

Patients with a second malignancy requiring treatment.

Patients with uncontrolled active infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • venetoclax, azacitidine and HAAG regimen

    Drug

    Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: VA combined with HAAGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite complete response rate (CRc; CR+CRi)

CRc includes complete response CR and CRi; CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia.

Time frame
Day 28-35 of induction course

Secondary outcomes

1

Partial remission (PR)

PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.

Time frame
Day 28-35 of induction course
2

Number of adverse events

adverse events are evaluated with CTCAE V5.0.

Time frame
2 years
3

Relapse-free survival (RFS)

time from clinical CRc (CR and CRi) to the first relapse or death

Time frame
3 years
4

Overall survival (OS)

time from the first day of treatment to death or lost to follow-up for any cause.

Time frame
3 years

Other outcomes

Sponsors and contacts

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