Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07178912

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)

Conditions: Phase II Clinical Trial, Blinatumomab, Olverembatinib, Lymphoblastic Leukemia, Philadelphia Chromosome Positive

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: M.D. Anderson Cancer Center

Location: MD Anderson Cancer Center Houston Texas

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.

Eligibility Criteria

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 \470 msec) unless corrected after electrolyte replacement or approved by cardiologist * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated thrombosis will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility * Uncontrolled hypertension (diastolic blood pressure \>90 mmHg, systolic \>140 mmHg). Participants with hypertension should be under treatment on study entry for blood pressure control. * History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Participants with active CNS leukemia will not be excluded. * Current autoimmune disease or history of autoimmune disease with potential CNS involvement. * Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days before study entry, unless full recovery from side effects has occurred or Participant has rapidly progressive disease judged to be life-threatening by the investigator. * Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. * History of significant bleeding disorder unrelated to cancer, including: * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies). * Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07178912). StuddyBuddy aggregates publicly available trial information.