Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age <18 years

Weight ≥40kg

Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome

Alanine aminotransferase (ALT) ≤ 3 x ULN, OR

Disqualifiers

Active serious infection not controlled by oral or intravenous 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.

Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.

Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist

Trial design

Design model

Single group

Treatments tested in this trial

  • Blinatumomab

    Drug

    Given by Infusion

  • Asciminib

    Drug

    Given by PO

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Blinatumomab + AsciminibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and adverse events (AEs)

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

Novartis Pharmaceuticals

Collaborator