Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.

Eligibility criteria

Qualifiers

Adult participants age ≥18 years.

Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase.

Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for ≤ 30 days are eligible.

Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.

Disqualifiers

Participants who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.

Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.

Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.

Participants who are receiving any other investigational agents.

Trial design

Treatments tested in this trial

  • olverembatinib

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Ascentage Pharma Group Inc.

Collaborator