Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic… (NCT02997761) | Clinical Trial Compass
CompletedPhase 2
Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
United States19 participantsStarted 2017-06-27
Plain-language summary
This phase II trial studies how well ibrutinib and blinatumomab work in treating patients with B acute lymphoblastic leukemia that has come back or is not responding to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating patients with relapsed or refractory B 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:
* Pathologically confirmed diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia/lymphoma with measurable bone marrow lymphoblasts or biopsy-proven extramedullary site measurable by computed tomography (CT) or positron emission tomography (PET)/CT imaging; Philadelphia chromosome-positive (Ph+) B-ALL patients must have failed treatment with at least one second generation tyrosine kinase inhibitor; prior allo-HCT is allowed
* No hematologic parameters for inclusion; transfusion-dependent patients are eligible and platelet counts should be maintained greater than 10,000/mm\^3 throughout cycles 1 and 2
* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or B-ALL or non-hepatic origin)
* Serum aspartate transaminase (aspartate aminotransferase \[AST\]) or alanine transaminase (alanine aminotransferase \[ALT\]) less than or equal to 3 x ULN (unless due to B-ALL)
* Estimated creatinine clearance greater than or equal to 30 ml/min (Cockcroft-Gault) or serum creatinine less than or equal to 2 x ULN
* Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time \[aPTT\]) =\< 1.5 x ULN (unless B-ALL related)
* Karnofsky performance status (KPS) performance status of 60% or greater
* Ability to understand and willingness to sign an informed consent form
* Ability to adhere to the study visit sc…
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 combined ibrutinib with blinatumomab specifically for relapsed or refractory B-cell ALL — since my leukemia has already come back or stopped responding to treatment, is this kind of combination approach something worth considering for my situation?
2The trial focused on patients who are Philadelphia chromosome positive — do my test results show whether I have this chromosome, and does that affect which treatments are most appropriate for me?
3Since this is a completed Phase 2 trial, what did the results show about the rate of complete remission, and how does that compare to other options available to me now?
4Phase 2 trials are designed to test whether a treatment shows enough promise to study further, but they're not always large enough to give a full picture of long-term safety — are there any known risks from combining ibrutinib and blinatumomab that you'd want me to understand before we discuss next steps?
5Given that this trial is now completed and I wouldn't be able to enroll, are there other active trials or standard treatments based on similar approaches — like BTK inhibitors or bispecific T-cell engagers — that might be worth exploring for my case?
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
Rate of Complete Remission (CR).
Timeframe: Up to about 3 months from start of study treatment.