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Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML

NCT05020665 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-01-10

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).

Conditions

  • Nucleophosmin 1-mutated Acute Myeloid Leukemia

Interventions

DRUG

Entospletinib

400 mg, Orally as tablets

DRUG

Placebo

Orally as tablets

DRUG

Cytarabine

Continuous infusion

DRUG

Anthracycline

Either daunorubicin or idarubicin was administered via slow intravenous (IV) push

Sponsors & Collaborators

  • Kronos Bio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2023-03-30
Completion
2023-03-30
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05020665 on ClinicalTrials.gov