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Trial Title:
Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT ID:
NCT06308588
Condition:
Philadelphia Chromosome-Positive
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Blinatumomab
Asciminib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
Given by Infusion
Arm group label:
Blinatumomab + Asciminib
Intervention type:
Drug
Intervention name:
Asciminib
Description:
Given by PO
Arm group label:
Blinatumomab + Asciminib
Other name:
ABL001
Summary:
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
Detailed description:
Primary Objectives
- Phase I: To determine the minimum safe and biologically effective dose of asciminib
in combination with asciminib
- 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
Criteria for 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 ≥ 18 years of age with relapsed/refractory
Ph-positive ALL or with previously treated lymphoid blast phase CML
2. Performance status ≤2 (ECOG Scale)
3. 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
4. Adequate renal function defined as:
a) Creatinine clearance ≥30 mL/min
5. Adequate pancreatic function as defined by the following criteria:
a) Serum lipase and amylase < 1.5 x ULN
6. Adequate cardiac function as assessed clinically by history and physical
examination.
7. For females of childbearing potential, a negative urine pregnancy test must be
documented
8. 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
9. Ability to understand and the willingness to sign a written informed consent
document.
10. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicholas Short, MD
Phone:
713-563-4485
Email:
nshort@mdanderson.org
Investigator:
Last name:
Nicholas Short, MD
Email:
Principal Investigator
Start date:
August 5, 2024
Completion date:
May 1, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06308588
http://www.mdanderson.org