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

Phase 2

Recruiting

• Conditions: Philadelphia Chromosome-Positive; Acute Lymphoblastic Leukemia

• Registration Number: NCT06308588
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Diagnosis of one of the following:<br><br> a) Participants =18 years of age with previously untreated or minimally pretreated<br> Ph-positive ALL who are not suitable candidates for intensive chemotherapy.<br> Participants who have received no more than one or two courses of chemotherapy with<br> or without other TKIs are considered minimally pretreated and still eligible if they<br> have persistently detectable MRD.<br><br> i. If they are in morphologic remission at enrollment, they are evaluable only MRD<br> responses, RFS and OS b) Participants = 18 years of age with relapsed/refractory<br> Ph-positive ALL or with previously treated lymphoid blast phase CML<br><br> 2. Performance status =2 (ECOG Scale)<br><br> 3. Adequate liver function as defined by the following criteria (unless the increased<br> values are judged to be leukemia disease related):<br><br> 1. Total serum bilirubin = 2 x upper limit of normal (ULN), unless due to<br> Gilbert's syndrome<br><br> 2. Alanine aminotransferase (ALT) = 3 x ULN, OR<br><br> 3. Aspartate aminotransferase (AST) = 3 x ULN<br><br> 4. Adequate renal function defined as:<br><br> a) Creatinine clearance =30 mL/min<br><br> 5. Adequate pancreatic function as defined by the following criteria:<br><br> a) Serum lipase and amylase < 1.5 x ULN<br><br> 6. Adequate cardiac function as assessed clinically by history and physical<br> examination.<br><br> 7. For females of childbearing potential, a negative urine pregnancy test must be<br> documented<br><br> 8. Willingness to use adequate contraception prior to study entry, for the duration of<br> study participation, and for 4 months after completion of study participation. For<br> women of child-bearing potential, adequate methods of contraception include:<br> complete abstinence, hormonal contraception (i.e. birth control pills, injection,<br> implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation<br> or hysterectomy, subject/partner post vasectomy, implantable or injectable<br> contraceptives, and condoms plus spermicide<br><br> 9. Ability to understand and the willingness to sign a written informed consent<br> document.<br><br> 10. Signed informed consent<br><br>Exclusion Criteria:<br><br> 1. Active serious infection not controlled by oral or intravenous antibiotics.<br><br> 2. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or<br> squamous cell carcinoma) that in the investigator's opinion will shorten survival to<br> less than 1 year.<br><br> 3. Active Grade III-V cardiac failure as defined by the New York Heart Association<br> Criteria.<br><br> 4. Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec) unless corrected<br> after electrolyte replacement or approved by cardiologist<br><br> 5. History or presence of clinically relevant CNS pathology such as epilepsy, childhood<br> or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia,<br> Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.<br> (Participants with active CNS leukemia will NOT be excluded)<br><br> 6. Treatment with any investigational antileukemic agents or chemotherapy agents in the<br> last 7 days before study entry, unless full recovery from side effects has occurred<br> or patient has rapidly progressive disease judged to be life-threatening by the<br> investigator. Cytarabine 2 g/m2 (or alternative) for cytoreduction is permitted.<br><br> 7. Pregnant and lactating women will not be eligible; women of childbearing potential<br> should have a negative pregnancy test prior to entering on the study and be willing<br> to practice methods of contraception. Women do not have childbearing potential if<br> they have had a hysterectomy or are postmenopausal without menses for 12 months. In<br> addition, men enrolled on this study should understand the risks to any sexual<br> partner of childbearing potential and should practice an effective method of birth<br> control.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)