A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblast… (NCT05386576) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
United States12 participantsStarted 2022-06-16
Plain-language summary
The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.
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:
* Adult patients with newly diagnosed Philadelphia chromosome (Ph) negative ALL.
* Patients with T- or B-cell lymphoblastic lymphoma with no bone marrow involvement will also be eligible for the study.
* Age 18-60
* ECOG performance status of 0-2
* Adequate renal function as demonstrated by a calculated creatinine clearance of ≥ 60 ml/min.
* Adequate hepatic function as demonstrated by a total bilirubin ≤ 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia)
* Patients with central nervous system (CNS) involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days.
* Negative serum pregnancy test in women of childbearing potential
Exclusion Criteria:
* CML in lymphoid blast crisis, mature B-cell (i.e. Burkitt's) lymphoma or mixed phenotype acute leukemia (MPAL)
* Prior treatments for ALL, except any doses of corticosteroids and hydroxyurea or one dose of vincristine
* Patients who received strong an…
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.
1Since this is an early Phase 1 trial primarily focused on finding a safe dose of venetoclax combined with chemotherapy rather than proving it works, what does that mean for how much we know about both the risks and the potential benefits for someone in my situation?
2The trial is measuring dose-limiting toxicities as its main goal — what kinds of serious side effects have been seen so far with venetoclax added to ALL chemotherapy, and how would those be managed if they happened to me?
3Since the trial is no longer actively recruiting, is there any way to find out what safety data has been collected so far, and would that information change how you think about treatment options for me?
4Given that this is a newly diagnosed ALL situation, would you recommend trying a standard established treatment first, and under what circumstances would adding an experimental drug like venetoclax to chemotherapy make more sense for my specific case?
5How does my particular type of ALL — such as whether it's B-cell or T-cell, or whether I have certain genetic markers — affect whether the venetoclax plus chemotherapy approach being studied here would even be relevant to discuss with my care team?
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.
What they're measuring
1
proportion of patients who have a Dose Limiting Toxicities