Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients Wit… (NCT07178912) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)
United States60 participantsStarted 2026-08-27
Plain-language summary
To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.
Who can participate
Age range18 Years
SexALL
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Eligibility Criteria
* Diagnosis of one of the following:
o Participants ≥18 years of age with newly diagnosed or relapsed/refractory Ph-positive and/or BCR::ABL1-positive ALL (includes Participants initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. Participants with newly diagnosed disease could have received one or two courses of chemotherapy with or without other TKIs and still eligible (Participants with lymphoid accelerated or blast phase CML will be evaluated separately).
* Performance status ≤2 (ECOG Scale).
* Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):
* Total serum bilirubin \<2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 x ULN.
* Adequate pancreatic function as defined by serum lipase and amylase \<1.5 x ULN.
* For females of childbearing potential, a negative urine pregnancy test must be documented.
* Female Participants who:
* Are postmenopausal for at least 1 year before the screening visit, OR
* Are surgically sterile, OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.
* Male Partici…
What they're measuring
1
safety and adverse events
Timeframe: Through study completion; an average of 1 year