Philadelphia Chromosome-PositivePhase 1/2NCT06308588
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Blinatumomab and Asciminib in people with Philadelphia Chromosome-Positive and Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Chromosome-Positive, Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab and Asciminib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Aug 2024to 1 May 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of one of the following:
- 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.
- 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
- 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):
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- 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:
- Creatinine clearance ≥30 mL/min
- Adequate pancreatic function as defined by the following criteria:
- Serum lipase and amylase < 1.5 x ULN
- Adequate cardiac function as assessed clinically by history and physical examination.
- For females of childbearing potential, a negative urine pregnancy test must be documented
- 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
- Ability to understand and the willingness to sign a written informed consent document.
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Nicholas Short, MD, 713-563-4485, nshort@mdanderson.org
Nicholas Short, MD
- Not yet recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10467
Marina Konopleva, MD, 718-920-4826, Marina.Konopleva@einsteinmed.edu
Marina Konopleva, MD
About this study
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Read the detailed description
Primary Objectives
- Phase I: To determine the minimum safe and biologically effective dose of asciminib in combination with blinatumomab
- Phase II: To evaluate the rate of NGS measurable residual disease (MRD) negativity using the clonoSEQ® assay in cohort 1 (newly diagnosed Ph-positive ALL) and the overall response (CR+CRi) rate in cohort 2 (relapsed/refractory disease).
Secondary Objectives
- To evaluate other clinical efficacy endpoints (complete molecular response [CMR] rate, CR rate, relapse-free survival and overall survival)
- To determine the safety of the combination regimen
Exploratory Objectives
- To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse
- To assess concordance/discordance between MRD assessed by PCR for BCR::ABL1 and next-generation sequencing MRD
- To determine the effect of the combination regimen on immune cell subsets
- Being tested
- Blinatumomab, Asciminib
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Given by Infusion
AsciminibDrug
Also called ABL001
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab + Asciminib | Experimental | Participants found to be eligible to take part in this study will receive 5 cycles of blinatumomab and asciminib, followed by asciminib alone for as long as it benefits the participant.
Participants will receive blinatumomab as a continuous (non-stop) infusion on Days 4-31 of Cycle 1 and on Days 1-28 of Cycles 2-5.
Participants will take asciminib by mouth 2 times every day during this study. Receives: Drug: Blinatumomab; Drug: Asciminib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start5 Aug 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Philadelphia Chromosome-PositiveStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nicholas Short, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308588
- Sponsor's protocol ID
- 2024-0054
- Other IDs
- NCI-2024-02121
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463