Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblasti… (NCT03488225) | Clinical Trial Compass
TerminatedPhase 2
Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia
Stopped: the study was closed early due to competing trials
United States4 participantsStarted 2018-03-28
Plain-language summary
This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.
Who can participate
Age range
16 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 newly diagnosed, previously untreated B-lineage ALL, or having achieved complete remission (CR) with one course of induction chemotherapy
* Patients with extramedullary disease only are eligible
* Failure to one induction course of chemotherapy (these patients will be analyzed separately)
* Performance status of 0-3
* Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)
* Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
* Adequate cardiac function as assessed by history and physical examination
* No active or co-existing malignancy with life expectancy less than 12 months
* Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active
Exclusion Criteria:
* Pregnant or nursing women
* Known to be human immunodeficiency virus (HIV)-positive
* Philadelphia chromosome (Ph)-positive ALL
* Active and uncontrolled disease/infection as judged by the treating physician
* Unable or unwilling to sign the consent form
* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable chronic liver disease per investigator assessment)
* Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infe…
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 trial was terminated before completing its planned enrollment, what does that mean for the reliability of the event-free survival data it collected, and should that affect how we think about inotuzumab ozogamicin as part of my treatment plan?
2This trial specifically focused on Philadelphia chromosome-negative B-ALL — does my leukemia's genetic profile match that, and how does that affect which treatments my doctor thinks are most appropriate for me?
3Because this is a Phase 2 trial that was terminated, does that mean there are safety or efficacy concerns I should know about before considering inotuzumab ozogamicin in combination with chemotherapy?
4Since the trial is no longer recruiting, are there other active trials or standard chemotherapy regimens for B-ALL in remission that my doctor would recommend instead, and how do they compare to what this study was testing?
5What was the likely reason this trial was terminated — was it due to safety signals, low enrollment, or something else — and how should that factor into any decisions we make about my care?
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.