Active — Not RecruitingPhase 2

Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

United States17 participantsStarted 2020-03-30

Plain-language summary

The purpose of this study is to test whether blinatumomab in combination with TKI therapy (such as dasatinib) is an effective treatment for people with Ph+ ALL. Researchers want to improve the response to standard-of-care treatment of corticosteroids + TKI therapy by adding the study drug, blinatumomab.

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: * Able to give informed consent * Age ≥ 18 years of age * Direct bilirubin ≤2x upper limit of normal (ULN), AST and ALT ≤10x upper limit of normal (ULN). Higher bilirubin and AST/ALT levels are acceptable if thought related to Ph+ ALL. * Histology confirmed by enrolling institution Confirmed diagnosis of acute lymphoblastic leukemia (ALL) by morphology, immunohistochemistry, and/or multiparameter flow cytometry, with confirmation of Philadelphia chromosome positivity (Ph+) by cytogenetic studies (karyotype/FISH), molecular studies (BCRABL1 fusion transcripts), or targeted RNA sequencing * No prior therapy for ALL beyond corticosteroids, hydroxyurea, or prophylactic intrathecal/intra-Ommaya chemotherapy Acceptable end-organ function (i.e. not meeting exclusion criteria below) * Amenable to practicing an effective method of birth control during treatment and for at least 3 months following treatment on study * ECOG performance status 0-2 Exclusion Criteria: * Philadelphia chromosome-negative ALL * Mature B-cell ALL (e.g. Burkitt leukemia/lymphoma) * Active extramedullary disease at time of study entry, including known CNS-3 disease (≥5 WBC/microliter and positive cytology or flow cytometry). Note: LP and/or CNS imaging prior to treatment initiation is not required, but if the patient is found to have active CNS-3 disease (by LP) or evidence of CNS involvement on imaging in the course of evaluation of clinical findings, enrollment is not permissible. * Pre…

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 combines blinatumomab with a tyrosine kinase inhibitor for Philadelphia chromosome-positive ALL — is my leukemia Philadelphia chromosome-positive, and would that make this combination worth discussing as an option for me?
2Since this is a Phase 2 trial, what do we know so far about the safety profile of blinatumomab combined with a tyrosine kinase inhibitor, and what side effects should I be most prepared for?
3The trial is no longer enrolling new patients — does that mean the results will be available soon, and could those findings change the standard treatment approach you'd recommend for me?
4The main thing this trial is measuring is whether patients achieve a complete molecular response, meaning no detectable leukemia at the genetic level — how does that goal compare to what we'd aim for with standard treatment options right now?
5Given that this trial is closed to new enrollment, are there other open studies or approved treatment combinations for Philadelphia chromosome-positive ALL that are based on a similar approach that we should be looking into together?

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

Proportion of evaluable patients achieving complete molecular response

Timeframe: 7 months

Trial details

NCT IDNCT04329325

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials