A trial comparing the effectiveness and safety of venetoclax to standard chemotherapy in acute myeloid leukaemia patients

Phase 2

• Conditions: Acute myeloid leukaemia; Cancer; Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue

• Registration Number: ISRCTN15567173
• Lead Sponsor: niversity of Birmingham

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36376888/ (added 23/11/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Last Update Posted: 8 July 2024
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Current inclusion criteria as of 09/02/2024:
1. Diagnosis of CD33-positive acute myeloid leukaemia
2. Age >=55 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
3. Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
5. Serum creatinine <=1.5 x ULN (upper limit of normal)
6. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=2.5 ULN and bilirubin <=2 x ULN
7. Able to provide written informed consent
8. Considered fit for intensive chemotherapy with anthracyclines by treating physician

Previous inclusion criteria:
1. Diagnosis of CD33-positive acute myeloid leukaemia
2. Age >=60 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
3. Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
5. Serum creatinine <=1.5 x ULN (upper limit of normal)
6. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=2.5 ULN and bilirubin <=2 x ULN
7. Able to provide written informed consent
8. Considered fit for intensive chemotherapy with anthracyclines by treating physician

Exclusion Criteria

1. Previous chemotherapy for AML or any antedecent haematological condition, with the exception of hydroxycarbamide to control white blood cell count
2. Other active malignancy requiring treatment
3. 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
4. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
5. Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment
6. Unable to swallow tablets whole
7. Known hypersensitivity to any of the IMPs
8. Patients known to require vaccination with a live vaccine during the treatment period

Study & Design

• Study Type: Interventional
• Study Design: Not specified