Actively Recruiting
A Phase I/II Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory T-ALL/LBL
Led by University of Chicago · Updated on 2026-03-18
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental drug called LP-118 to understand its side effects and find safe doses. This study also aims to see if LP-118 can be safely combined with ponatinib, an FDA-approved medicine for acute lymphoblastic leukemia. The trial focuses on patients with relapsed or refractory T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma. Participants will receive LP-118 and ponatinib together in increasing or decreasing doses to find the highest safe dose. They will also get standard chemotherapy with vincristine, dexamethasone, and methotrexate. Treatments are given in 21-day cycles, with LP-118 and ponatinib taken daily at home. The first cycle includes seven study visits, while subsequent cycles have five visits each. During the study, participants will have regular visits for monitoring, lab tests, and assessments. Researchers will evaluate safety and determine recommended doses over 36 weeks. They will also measure remission rates, survival, and disease progression. The study includes informed consent, organ function checks, and contraception requirements. Participation lasts through treatment cycles with ongoing safety monitoring.
CONDITIONS
Brief Title
A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma
- 18 years old or older
- Bone marrow or peripheral blood involvement with at least 5% lymphoblasts or measurable residual disease above 10-4 by flow cytometry or next-generation sequencing
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate organ function including creatinine clearance at least 50 mL/min and liver enzymes within specified limits
- At least 2 weeks from major surgery or radiation therapy and recovered from prior treatment toxicities
- Voluntary signed informed consent
- Females of childbearing potential must use effective contraception during treatment and for 8 months after last dose; males with female partners must use contraception during treatment and for 5 months after last dose
- Willingness and ability to comply with study visits, treatment, and procedures
You will not qualify if you...
- Active central nervous system leukemia
- Active or chronic hepatitis B or C infection or known HIV infection with detectable viral load
- Major surgery within less than 2 weeks before randomization
- Unstable or severe uncontrolled medical conditions such as cardiac or pulmonary issues
- Concurrent active cancers other than specified exceptions or untreated malignancies
- Uncontrolled cardiac disease
- Pregnant or breastfeeding females or those not agreeing to use highly effective contraception
- Participation in other investigational studies during active treatment phase
- Other severe acute or chronic medical, psychiatric conditions, or laboratory abnormalities that increase risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks
Participants receive the experimental drugs LP-118 and ponatinib daily at home, combined with standard chemotherapy drugs vincristine, dexamethasone, and methotrexate. The treatment cycles last 21 days each, with doses adjusted to find the safest and most effective levels.
7 visits in the first 21-day cycle and 5 visits per cycle for cycles 2 through 12
Trial Site Locations
Total: 2 locations
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60615
Actively Recruiting
2
University of Rochester Medical Center, Wilmot Cancer Center
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
C
Caner Saygin, MD
W
Wendy Stock, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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