A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagn… (NCT03914625) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
United States, Australia, Canada6,720 participantsStarted 2019-07-03
Plain-language summary
This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.
Who can participate
Age range
365 Days – 31 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:
* All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731.
* Age at diagnosis:
* Patients must be \>= 365 days and \< 10 years of age (B-ALL patients without DS).
* Patients must be \>= 365 days and =\< 31 years of age (B-ALL patients with DS).
* Patients must be \>= 365 days and =\< 31 years of age (B-LLy patients with or without DS).
* B-ALL patients without DS must have an initial white blood cell count \< 50,000/uL (performed within 7 days prior to enrollment).
* B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment).
* Patient has newly diagnosed B-cell ALL, with or without Down syndrome: \> 25% blasts on a bone marrow (BM) aspirate;
* OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy;
* OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells;
* OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without Down syndrome.
* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks),…
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.
1This trial is specifically studying blinatumomab added to standard chemotherapy for newly diagnosed B-ALL — since it's a Phase 3 study already in active enrollment, what does my doctor know so far about how blinatumomab is affecting disease-free survival compared to chemotherapy alone?
2The trial separates patients into risk groups like standard risk average, standard risk high, and standard risk favorable — which group would I likely fall into, and does that affect whether adding blinatumomab would even be relevant to my situation?
3Since the trial is no longer actively recruiting, is there any other way to access blinatumomab as part of my treatment, or should we be focusing on a standard chemotherapy regimen instead?
4This trial includes a specific focus on boys and on patients with Down syndrome as separate groups — if I or my child falls into one of those categories, how does that change what my doctor thinks about this approach versus standard treatment?
5Because disease-free survival is the main thing being measured, how long would my doctor estimate it takes to know whether adding blinatumomab is actually making a difference, and what does that mean for the decisions we need to make right now?
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
Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab
Timeframe: 5.3 years
2
DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)