Acute Myeloid Leukemia Treated With With NETrin Abs in Combination With [AZACITIDINE + VENETOCLAX]

Sponsor
Centre Leon Berard
Study ID
NCT06150040
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Acute Myeloid Leukemia Refractory

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NP137 — DRUG
    IV infusion, 14mg/kg or 9mg/kg, every 2 weeks
  • Azacitidine Injection — DRUG
    Subcutaneous injection, 75 mg/m², on cycle Days 1-7 (28-days cycle)
  • Venetoclax — DRUG
    Orally, 70 mg, every day on Days 1-28

Study Details

The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with Azacitidine and Venetoclax in patients with refractory acute myeloid leukemia after 2 cycles of Azacitidine and Venetoclax.

Key Dates

Start date
Sep 11, 2024
Status verified
Feb 2025
Primary completion
Feb 18, 2025
Completion
Feb 18, 2025

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Refractory Acute Myeloid Leukemia
    Patients who meet primary refractory disease definition according to ELN criteria after 2 cycles of standard \[AZACITIDINE +VENETOCLAX\] (i.e: patients who have failed to have a complete remission (with complete (CR) or incomplete hematologic recovery (CRi))

Primary Outcome Measure

Safety run in part : Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: 4 weeks ]

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