Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether blinatumomab and asciminib together can help control Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer. It is for certain adults with new or lightly treated Ph+ ALL, and people age 12 or older with Ph+ ALL that came back or did not respond to treatment, or a previously treated form of advanced chronic myeloid leukemia (CML).
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have one of these diagnoses: age 18 or older with new or lightly treated Ph+ ALL and unable to have intensive chemotherapy; OR age 12 or older with Ph+ ALL that came back or resisted treatment, or previously treated CML in lymphoid blast phase, an advanced stage. Lightly treated means no more than 1–2 chemotherapy courses, with small amounts of leukemia still found by testing.
- Meet the study's activity level requirements: ECOG score 2 or lower for adults, or Lansky score 50 or higher for those under 18.
- Weigh at least 40 kg (about 88 pounds).
- Have liver blood tests within study limits, unless abnormal results are due to leukemia. A bilirubin exception also applies for Gilbert's syndrome.
- Have kidney and pancreas tests within study limits, and heart function judged adequate by medical history and an exam.
- Have a negative urine pregnancy test if you can become pregnant.
- Be willing to use suitable birth control before joining, during the study, and for 4 months afterward.
- Be able to understand the study and sign a consent form.
Who can't join
- Have a serious active infection that antibiotics are not controlling.
- Have another active cancer, other than skin cancer, that the study doctor thinks will shorten survival to less than 1 year.
- Have active severe heart failure.
- Have a QTc over 470 milliseconds on a heart tracing—a delay in the heart's electrical recovery—unless corrected by replacing body salts or approved by a heart doctor.
- Have a significant brain or nervous system condition, such as seizures, stroke, serious brain injury, dementia, Parkinson's disease, or psychosis. Leukemia in the brain or spinal cord does not itself rule you out.
- Have received experimental leukemia drugs or chemotherapy within 7 days before joining, unless side effects have fully cleared or the leukemia is rapidly worsening and life-threatening. Cytarabine or an alternative to lower leukemia cell counts is allowed.
- Are pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Diagnosis of one of the following: a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy with or without other TKIs are considered minimally pretreated and still eligible if they have persistently detectable MRD. i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid blast phase CML 2. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years 3. Weight ≥40kg 4. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related): 1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome 2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR 3. Aspartate aminotransferase (AST) ≤ 3 x ULN 5. Adequate renal function defined as: a) Creatinine clearance ≥30 mL/min 6. Adequate pancreatic function as defined by the following criteria: a) Serum lipase and amylase \< 1.5 x ULN 7. Adequate cardiac function as assessed clinically by history and physical examination. 8. For females of childbearing potential, a negative urine pregnancy test must be documented 9. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide 10. Ability to understand and the willingness to sign a written informed consent document. 11. Signed informed consent Exclusion Criteria: 1. Active serious infection not controlled by oral or intravenous antibiotics. 2. 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. 3. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria. 4. Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist 5. 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) 6. 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. 7. 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.
Study sites (2)
NY
- Montefiore Einstein Comprehensive Cancer Center · The Bronx, NY 10467Marina Konopleva, MD · Study contact · 718-920-4826 · Marina.Konopleva@einsteinmed.eduMarina Konopleva, MD · Principal investigatorMore trials in The Bronx
TX
- MD Anderson Cancer Center · Houston, TX 77030Nicholas Short, MD · Study contact · 713-563-4485 · nshort@mdanderson.orgNicholas Short, MD · Principal investigatorMore trials in Houston