A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With 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: BL-M11D1, Cytarabine, Daunorubicin, Venetoclax.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: 18 years — 75 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 →
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Official title
A Phase II/III Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M11D1 for Injection in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Overview
This study is an open, multicenter, dose-escalation and expansion, non-randomized phase II/III clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M11D1 in combination with cytarabine + daunorubicin or venetoclax + azacitidine in patients with acute myeloid leukemia.
Detailed description
The study cohorts include: Cohort A: Untreated newly diagnosed acute myeloid leukemia patients treated with BL-M11D1 in combination with cytarabine + daunorubicin. Cohort B: Untreated newly diagnosed acute myeloid leukemia patients treated with BL-M11D1 in combination with venetoclax + azacitidine.
Interventions
- Drug BL-M11D1
Administration by intravenous infusion for a cycle of 4 weeks. - Drug Cytarabine
Administration in 4-week cycles. - Drug Daunorubicin
Administration in 4-week cycles. - Drug Venetoclax
Administration in 4-week cycles. - Drug Azacitidine
Administration in 4-week cycles.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
- Composite Response Rate（CRc） [Time frame: Up to approximately 24 months]
- Phase IIa: Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]
Secondary outcome measures (8)
- Progression-free survival (PFS) [Time frame: Up to approximately 24 months]
- Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
- Relapse-Free Survival (RFS) [Time frame: Up to approximately 24 months]
- Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
- Cmax [Time frame: Up to approximately 24 months]
- Tmax [Time frame: Up to approximately 24 months]
- Ctrough [Time frame: Up to approximately 24 months]
- ADA (anti-drug antibody) [Time frame: Up to approximately 24 months]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 years;
- Expected survival time ≥3 months;
- Newly diagnosed AML according to the World Health Organization (WHO) 2016 classification and confirmed by morphology;
- ECOG performance status score ≤2;
- Peripheral blood white blood cell count ≤25×10⁹/L before the first dose;
- Organ function levels must meet the requirements;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum/urine pregnancy test must be negative. Patients must not be breastfeeding; all enrolled patients (regardless of male or female) should adopt adequate barrier contraception throughout the entire treatment cycle and for 6 months after the end of treatment.
Exclusion criteria
- Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia;
- Previous treatment for AML;
- Participation in other interventional or observational studies;
- History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of other malignancies within 5 years prior to the first dose;
- Poorly controlled hypertension;
- Grade ≥3 lung disease as defined by CTCAE v5.0, history of interstitial lung disease requiring systemic steroid therapy, etc.;
- Patients with central nervous system involvement;
- Previous organ transplantation;
- History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M11D1;
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Evidence of other clinically significant, poorly controlled infections requiring systemic treatment;
- Clinically symptomatic or recurrent pleural, peritoneal, pelvic, or pericardial effusion requiring drainage;
- Pregnant or lactating women;
- Within 4 weeks prior to the first dose of the study drug, subjects must not have received any live vaccines or are not expected to receive live vaccines during the study participation;
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07255872 · BL-M11D1-201