Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: A Molecularly Guided Phase 2 Study

Phase 1

• Conditions: Acute Myeloid Leukaemia; MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000273-24-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-21
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

•Diagnosis of CD33 positive Acute Myeloid Leukaemia
•Age =60 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
•Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Serum creatinine = 1.5 x ULN (upper limit of normal)
•Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) = 2.5 ULN and bilirubin = 2 x ULN
•Able to provide written informed consent
•Considered fit for intensive chemotherapy with anthracyclines by treating physician

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

•Previous chemotherapy for AML or any antedecent haematological condition, with the exception of hydroxycarbamide to control white blood cell count
•Other active malignancy requiring treatment
•Newly diagnosed or uncontrolled HIV or hepatitis B or C infection. Patients with known chronic infections may enrol if the last two tests for viral load have been negative and their current therapy does not include a protease inhibitor or a non-nucleoside reverse-transcriptase inhibitor
•Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
•Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment
•Unable to swallow tablets whole

Study & Design

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