VENETOCLAX for Acute myeloid leukaemia | Favourable-risk acute myeloid leukaemia

Inclusion criteria

• {"criterion_text":"- Diagnosis of CD33 positive Acute Myeloid Leukaemia"}
• {"criterion_text":"- Age ≥55 years"}
• {"criterion_text":"- Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-2"}
• {"criterion_text":"- Serum creatinine ≤ 1.5 x ULN (upper limit of normal)"}
• {"criterion_text":"- Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 ULN and bilirubin ≤ 2 x ULN"}
• {"criterion_text":"- Able to provide written informed consent"}
• {"criterion_text":"- Considered fit for intensive chemotherapy with anthracyclines by treating physician"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Molecular event-free survival time (mEFS). An event is defined as follows: a) Failure to achieve morphological CR or CRi after two cycles of therapy, b) Molecular persistence, progression or relapse requiring treatment change (at any time), c) Morphological relapse (at any time) or d) Death (at any time)","definition_or_measurement_approach":"mEFS defined as: (a) Failure to achieve morphological CR or CRi after two cycles of therapy; (b) Molecular persistence, progression or relapse requiring treatment change (at any time); (c) Morphological relapse (at any time); or (d) Death (at any time)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of morphological complete remission (CR or CRi) by the end of the second cycle of treatment (see protocol section 8.14 for definitions of morphological response)","definition_or_measurement_approach":"Assessment of morphological CR or CRi by end of cycle 2; see protocol section 8.14 for definitions of morphological response."}
• {"endpoint_text":"- Death within 30 and 60 days from trial entry","definition_or_measurement_approach":"All-cause mortality within 30 and 60 days from trial entry."}
• {"endpoint_text":"- Overall survival time","definition_or_measurement_approach":"Time from trial entry to death from any cause."}
• {"endpoint_text":"- Time to morphological relapse (see protocol section 8.14 for definitions of morphological response)","definition_or_measurement_approach":"Time from CR/CRi to morphological relapse as defined in protocol section 8.14."}
• {"endpoint_text":"- Time to molecular relapse (see protocol section 8.14 for definitions of molecular response)","definition_or_measurement_approach":"Time from molecular complete remission to molecular relapse as defined in protocol section 8.14."}
• {"endpoint_text":"- Cumulative occurrence of grade 3 and 4 adverse events at 12 and 24 months","definition_or_measurement_approach":"Cumulative count/incidence of grade 3 and 4 AEs at 12 and 24 months (CTCAE grading assumed)."}
• {"endpoint_text":"- Prevalence of molecular complete remission at month 3, 6 and 12","definition_or_measurement_approach":"Proportion of participants with molecular complete remission at months 3, 6 and 12."}
• {"endpoint_text":"- Cumulative resource use at 12 and 24 months including hospital admission days, blood product usage and days on intravenous antibiotics and antifungals","definition_or_measurement_approach":"Resource utilisation measures collected at 12 and 24 months: hospital admission days, blood product use, days on IV antibiotics/antifungals."}
• {"endpoint_text":"- Health-related quality of life at month 3, 6, 12, 18 and 24","definition_or_measurement_approach":"HRQoL assessments at months 3, 6, 12, 18 and 24 using the trial-specified instruments (not detailed in CTIS entry)."}
• {"endpoint_text":"- Change in performance status from baseline at month 3, 6, 12, 18 and 24","definition_or_measurement_approach":"Change from baseline in performance status measured at specified months."}
• {"endpoint_text":"- Change in Comprehensive Geriatric Assessment (CGA) from baseline at month 12 and 24","definition_or_measurement_approach":"Change from baseline in CGA at months 12 and 24."}

Denmark

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

540

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

The University Of Birmingham

Organisation Type

Educational Institution

Country Of Registered Address

United Kingdom

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"code:1","organisation_type":"Educational Institution"}
• {"country":"United Kingdom","full_name":"Sharp Clinical Services (UK) Limited","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Guy's And St Thomas' NHS Foundation Trust","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}