Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or … (NCT03808610) | Clinical Trial Compass
TerminatedPhase 1/2
Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia
Stopped: \<75% participation
United States53 participantsStarted 2019-04-03
Plain-language summary
This phase I/II trial studies the side effects and best dose of venetoclax and how well it works in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia that has not responded to treatment or that has come back. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, including vincristine, cyclophosphamide, dexamethasone, rituximab, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with low-intensity chemotherapy may work better in treating patient with B- or T-cell acute lymphoblastic leukemia.
Who can participate
Age range
18 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
. Diagnosis of one of the following
. Patients ≥ 18 years of age with relapsed/refractory B- or T-cell ALL (for phase II only)
. Patients ≥ 60 years of age with previously untreated B- or T-cell ALL. Patients \<60 years of age may be enrolled if they are considered unfit for intensive chemotherapy
. Patients ≥ 60 years of age with previously treated B- or T-cell ALL who received 1-2 courses of any frontline chemotherapy. Patients \<60 years of age may be enrolled if they are considered unfit for intensive chemotherapy
. Performance status ≤ 3 (Eastern Cooperative Oncology Group \[ECOG\] Scale)
. Adequate liver and renal function as defined by the following criteria:
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.
. For females of childbearing potential, a negative pregnancy test must be documented within 1 week of starting treatment
. Female and male patients who are fertile must agree to use an effective form of contraception (birth control methods while on study, such as birth control pills or injections, intrauterine devices \[IUDs\]), or double-barrier methods (for example, a condom in combination with spermicide) with their sexual partners for 4 months after the end of treatment
Exclusion criteria
. Patients with Philadelphia chromosome-positive ALL or Burkitt leukemia
. Patients who are willing and eligible to receive intensive chemotherapy (only for patients enrolling in frontline cohort)
. Active serious infection not controlled by oral or intravenous antibiotics
. Known CNS leukemia requiring radiation
. Active GVHD
. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
. Known hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
. Active grade III-V cardiac failure as defined by the New York Heart Association Criteria