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)

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Blinatumomab

    Drug

    Given by Iv

  • olverembatinib

    Drug

    Given by PO

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Treatment with Blinatumomab (SC) + Olverembatinib (PO) Q5WExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

safety and adverse events

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Amgen

Collaborator

Ascentage Pharma Group Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: