Dasatinib-Blinatumomab for Ph-Positive Acute Lymphoblastic Leukemia in Adults.
Robin Foà, Renato Bassan, Antonella Vitale...
https://pubmed.ncbi.nlm.nih.gov/33085860Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06220487
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-01-24
67
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for adults newly diagnosed with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This phase 2, single-arm, open-label study explores the safety and effectiveness of combining a third-generation tyrosine kinase inhibitor (Olverembatinib), a CD3/CD19 bispecific T-cell engager (Blinatumomab), and a histone deacetylase inhibitor (Chidamide), known as the ABC regimen. The study aims to improve early and deep complete molecular remission rates and overall outcomes for this leukemia subtype, especially in patients with high-risk genetic markers like IKZF1 deletions. Participants will receive treatment in phases over several years. Initially, after pretreatment with glucocorticoid, they undergo one year of induction and consolidation therapy with Olverembatinib, Blinatumomab, and Chidamide following a specific schedule of doses and cycles. This is followed by three years of maintenance therapy using Olverembatinib and Chidamide. After treatment, participants enter a five-year follow-up phase to monitor long-term effects and disease status. Throughout the study, participants will be closely monitored for complete molecular remission at three months and other outcomes such as overall survival, event-free survival, and adverse events over up to five years. Specific genetic subgroups like IKZF1del and IKZF1plus will be assessed for treatment response. Regular clinical evaluations, laboratory tests, and safety assessments are part of the study to track participants' health and treatment adherence during this multi-year trial.
CONDITIONS
Brief Title
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Newly diagnosed adult B-precursor Philadelphia Chromosome-positive acute lymphoblastic leukemia
- Age 18 years or older
- ECOG Performance Status 0-1
- Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Liver function tests (AST, ALT, AP) less than 2 times upper limit of normal
- Creatinine clearance of 50 mL/min or higher
- Serum amylase and lipase less than or equal to 1.5 times upper limit of normal
- Normal cardiac function
- Negative HIV test, negative HBV DNA, and negative HCV RNA
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Previous systemic chemotherapy or CAR-T therapy for acute lymphoblastic leukemia
- Impaired cardiac function including LVEF below 45%, complete left bundle branch block, use of a cardiac pacemaker, significant ECG abnormalities, congenital long QT syndrome, significant arrhythmias, bradycardia below 50 beats per minute, or prolonged QTc over 450 msec
- Myocardial infarction within 3 months before starting Olverembatinib
- Angina pectoris
- Gastrointestinal disorders affecting drug absorption such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection
- History or presence of autoimmune disease
- History or presence of relevant central nervous system pathology or CNS leukemia
- History of other malignancies
- Active infection
- Nursing women or women of childbearing potential unwilling to use effective contraception during and for 3 months after the study, or male patients unwilling to use contraception
- Not eligible for this study as decided by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 years
Participants receive the ABC regimen including Olverembatinib, Blinatumomab, and Chidamide. This regimen consists of a pretreatment phase, induction and consolidation therapy for 1 year, followed by maintenance therapy for 3 years.
Multiple treatment cycles over 1 year of induction and consolidation, followed by maintenance therapy for 3 years
Follow-up
Duration - 5 years
Participants are followed for safety and survival outcomes after treatment completion.
Visits according to follow-up schedule for up to 5 years
Trial Site Locations
Total: 1 location
1
Dept of Hematology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Loading map...
Research Team
H
Hongsheng Zhou, M.D; Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Ponatinib and blinatumomab for Philadelphia chromosome-positive acute lymphoblastic leukaemia: a US, single-centre, single-arm, phase 2 trial.
Elias Jabbour, Nicholas J Short, Nitin Jain...
https://pubmed.ncbi.nlm.nih.gov/36402146