Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Na… (NCT03709758) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve AML
United States50 participantsStarted 2018-10-17
Plain-language summary
This research study is studying the combination of venetoclax and chemotherapy as a possible treatment for acute myelogenous leukemia (AML).
The drugs involved in this study are:
* Venetoclax
* Daunorubicin
* Cytarabine
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with AML who are newly diagnosed according to the WHO 2016 Classification and previously untreated with the exception of hydroxyurea. ATRA pretreatment for suspected APL for less than 5 days is allowed. Eligible patients with AML arising from an antecedent hematologic disease (AHD) including MDS, may have been treated for their prior hematologic disease (except for allogenic transplant).
* AML patients include de-novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML).
* For a diagnosis of AML, a bone marrow or peripheral blast count of 20% or more is required.
* In AML with monocytic or myelomonocytic differentiation, monoblasts and promonocytes, but not abnormal mature monocytes, are counted as blast equivalents.
* Patients must be ≥18 and ≤60 years old.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. (See protocol Appendix D.)
* LVEF ≥ 45% by MUGA or ECHO at screening.
* Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
* Adequate liver function as demonstrated by:
* aspartate aminotransferase (AST) ≤ 2.5 × ULN\*
* alanine aminotransferase (ALT) ≤ 2.5× ULN\*
* total bilirubin ≤ 1.5 × ULN\*
* Unless considered due to leukemic organ involvement.
* Subjects with Gilbert's Syndrome may have a total bilirubin \> 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.