BridgeMD
A study to investigate the effect of adding cobicistat to venetoclax and azacitidine in patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy and have not received previous treatment.
EU CTIS ID: 2023-505379-61-00
What this study is testing
Run-in phase: To evaluate the pharmacokinetic (PK) equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2). Extentension phase: To assess the practical applicability and the therapeutic effect of a defined schedule of cobicistat added to venetoclax and azacitidine (AZA/VEN/COBI) on overall survival (OS) in adult patients with newly diagnosed AML considered ineligible for intensive chemotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia). Patients may have had previous treatment with erythropoiesis stimulating agents (ESA) for an antecedent phase of MDS. ESAs must be stopped at least two weeks before registration.
- Patients 18 years and older who are considered not fit for intensive chemotherapy (judged by treating physician) or who decline the option of intensive chemotherapy.
- WHO performance status 0, 1 or 2.
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection. Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert’s syndrome. Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.
- Male subjects who are sexually active, must agree, from Study Day 1 until at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.
- Female subjects must be either postmenopausal defined as: Age >55 years with no menses for ≥12 months, without an alternative medical cause. OR willing and able to use adequate contraception during and until 180 days after the last protocol treatment.
You likely can't join if
- Acute promyelocytic leukemia.
- History of non-compliance to medical regimens or considered unreliable with respect to compliance.
- Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Unreplaceable use of strong inhibitors or inducers of CYP3A or CYP3A/p-GP substrates with a narrow therapeutic window (e.g., cobicistat or ritonavir for HIV treatment).
See the full eligibility criteria
Who can join
- Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia). Patients may have had previous treatment with erythropoiesis stimulating agents (ESA) for an antecedent phase of MDS. ESAs must be stopped at least two weeks before registration.
- Patients 18 years and older who are considered not fit for intensive chemotherapy (judged by treating physician) or who decline the option of intensive chemotherapy.
- WHO performance status 0, 1 or 2.
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection. Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert’s syndrome. Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.
- Male subjects who are sexually active, must agree, from Study Day 1 until at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.
- Female subjects must be either postmenopausal defined as: Age >55 years with no menses for ≥12 months, without an alternative medical cause. OR willing and able to use adequate contraception during and until 180 days after the last protocol treatment.
- Written informed consent.
- Patient is capable of giving informed consent.
- Patient agrees not to participate in another interventional study while on protocol treatment without approval of the (co-) Principal Investigator.
What rules you out
- Acute promyelocytic leukemia.
- History of non-compliance to medical regimens or considered unreliable with respect to compliance.
- Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Unreplaceable use of strong inhibitors or inducers of CYP3A or CYP3A/p-GP substrates with a narrow therapeutic window (e.g., cobicistat or ritonavir for HIV treatment).
- Intolerability, contra-indication or allergy to one of the study drugs.
- Exclusion for the run-in phase only: Patient with a strong indication for IFD prophylaxis (or treatment)
- Myelodysplastic syndrome (MDS).
- Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea (previous treatment with hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis).
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion: except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 24 months prior to registration; except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Blast crisis of chronic myeloid leukemia.
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.).
- Cardiac dysfunction as defined by: Myocardial infarction within the last 3 months of study entry; or reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram; or unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure; or unstable cardiac arrhythmias.
- History of stroke or intracranial haemorrhage within 6 months prior to registration.
- Symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.