Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

ETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: >14 to 65 years (inclusive).

Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose <0.5g, and leukapheresis).

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

Expected survival >6 months.

Disqualifiers

Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential

Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.

Presence of central nervous system (CNS) leukemia.

Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

Trial design

Design model

Single group

Treatments tested in this trial

  • VEN (Venetoclax)

    Drug

    Orally

  • Azacitidine (AZA)

    Drug

    Subcutaneous injection

  • Chidamide

    Drug

    Orally

  • vindesine

    Drug

    intravenous infusion

  • Dexamethasone

    Drug

    intravenous infusion or orally

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and DexamethasoneExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Composite Complete Remission Rate(CRc) after induction therapy

Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)

Time frame
Time from the completion of induction and before consolidation therapy(up to 42 days)

Secondary outcomes

1

Overall survival(OS)

Time from the date of enrollment to death from any cause or the last follow-up

Time frame
2 years
2

Relapse-Free Survival(RFS)

The duration from the date of the first complete remisson to the occurrence of relapse, death from any cause, or the last follow-up.

Time frame
2 years
3

duration of remission (DOR)

Time between the first remission and relapse

Time frame
2 years
4

AE

Adverse events during the chemotherapy treatment.

Time frame
Within 30 days after the last chemotherapy

Other outcomes

Sponsors and contacts

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