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)

ConditionsPhase II Clinical Trial Blinatumomab Olverembatinib Lymphoblastic Leukemia Philadelphia Chromosome Positive

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Performance status ≤2 (ECOG Scale).

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.

Disqualifiers

Active serious infection not controlled by oral or IV antibiotics.

Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.

Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Myocardial infarction, stroke, or revascularization within 3 months

Trial design

Treatments tested in this trial

Blinatumomab
olverembatinib

Treatment groups

60 Participants

are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Amgen

Collaborator

Ascentage Pharma Group Inc.

Collaborator

Source ClinicalTrials.gov