RecruitingPhase 1/2

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

United States40 participantsStarted 2024-08-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosis of one of the following:
✓. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years
✓. Weight ≥40kg
✓. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):
✓. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
✓. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
✓. Aspartate aminotransferase (AST) ≤ 3 x ULN
✓. Adequate renal function defined as:

Exclusion criteria

✕. 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
✕. 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)
✕. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Cytarabine 2 g/m2 (or alternative) for cytoreduction is permitted.
✕. 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.

What they're measuring

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year.

Trial details

NCT IDNCT06308588

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Nicholas Short, MD

(713) 563-4485 nshort@mdanderson.org

View on ClinicalTrials.gov More Philadelphia Chromosome-Positive trials