A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This is a multicenter, prospective, phase II study for adult de novo Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ ALL) based on the combination of Olverembatinib and Blinatumomab. Olverembatinib will be taken 40mg qod from the time of diagnosis, and Blinatumomab will be given intravenously up to five cycles.

Eligibility criteria

Qualifiers

Male or non-pregnant, non-lactating female patients who are 18 years of age or older.

Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy. Participants who only received preconditioning can be enrolled.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.

Disqualifiers

Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCVpositive).

Uncontrolled active infection.

Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS.

Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) > 140mmHg and/or diastolic blood pressure > 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.

Trial design

Treatments tested in this trial

  • Olverembatinib

Treatment groups

22 Participants
are divided into 1 treatment group