CPX-351 versus intensive chemotherapy in patients with de novo intermediate or adverse risk AML stratified by genomics

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia; MedDRA version: 21.0Level: LLTClassification code: 10000886Term: Acute myeloid leukemia Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500295-60-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

De novo AML, No MRC-defining cytogenetic lesion, No t(15;17), t(8;21), inv(16) or t(16;16), No NPM1 gene mutation, No FLT3 mutated AML (FLT3 ITD or TKD), Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms,, Age above or equal to 50 years, Performance status below or equal to 2 (ECOG grading),

Exclusion Criteria

Prior history of documented MDS, MPN or MDS/MPN, tAML, Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer), Patient has active and uncontrolled infection., Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance., Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified