Menu
Recruiting NCT07078591

Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venetoclax, Azacitidine (AZA), Daunorubicin, Idarubicin（IDA）.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia

Overview

The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).

Interventions

  • Drug Venetoclax
    Given PO
  • Drug Azacitidine (AZA)
    Given SC
  • Drug Daunorubicin
    Given IV
  • Drug Idarubicin（IDA）
    Given IV
  • Drug Cytarabine (Ara-C)
    Given IV
  • Biological GPBMC infusion
    HLA-mismatched donor GPBMC infusion

Primary outcome measures

  • Overall survival (OS) [Time frame: Measured up to 4 years after the last participant is enrolled]
  • Event-free Survival (EFS) [Time frame: Measured up to 4 years after the last participant is enrolled]
Secondary outcome measures (3)
  • Complete remission (CR) and complete remission with incomplete marrow recovery (CRi) [Time frame: Measured up to 2 years after the last participant is enrolled]
  • Partial remission (PR) [Time frame: Measured up to 2 years after the last participant is enrolled]
  • Non-relapse Mortality (NRM) [Time frame: Measured up to 4 years after the last participant is enrolled]

Eligibility criteria

Inclusion criteria

  • Age >=18 years, male or female, non-limited by race or ethnicity.
  • No prior anti-acute leukemia treatment (including hypomethylators for leukemia or MDS) with the exception that prior hydroxyurea and/or leukapheresis are permitted.
  • Confirmed acute myeloid leukemia in accordance with WHO criteria with a WBC count < 25 × 109/L.
  • Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.
  • Adequate renal function including serum creatinine <= 2 × ULN or CrCl>= 40mL/min.
  • LVEF measured by echocardiogram is within the normal range (LVEF > 50%).
  • The subject must have one donor who is >= 18 years old and HLA matched at 0-7/10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form.
  • Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research.
  • Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.

Exclusion criteria

  • Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and blast crisis.
  • Uncontrolled infection or hemorrhage.
  • Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.
  • Uncontrolled autoimmune disease or requiring immunosuppression treatment.
  • History of severe blood infusion reaction.
  • Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
  • Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.
  • Any major surgery within 4 weeks before enrollment.
  • Life-threatening illness other than AML or uncontrolled intercurrent illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07078591 · VEN-MST for AML

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗