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Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine

NCT03588078 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-01-30

No results posted yet for this study

Summary

The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients

Conditions

  • Myelodysplastic Syndrome With Gene Mutation
  • Acute Myeloid Leukemia With Gene Mutations
  • Myeloproliferative Neoplasm
  • Chronic Myelomonocytic Leukemia

Interventions

DRUG

APR-246

Azacitidine at maximum tolerated dose. APR246 at the Dose limited Toxicity (DLT) dose

DRUG

Azacitidine

azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m2

Sponsors & Collaborators

  • Aprea Therapeutics

    collaborator INDUSTRY

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Pierre Fenaux · service Hématologie Séniors Hôpital Saint Louis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2020-05-01
Completion
2021-05-15
FDA Drug
Yes

Countries

  • France

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 NCT03588078 on ClinicalTrials.gov