Actively Recruiting
A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)
Led by University of Chicago · Updated on 2026-03-18
15
Participants Needed
2
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.
CONDITIONS
Official 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 5% lymphoblasts or measurable residual disease with >10-4 level detected by multiparameter flow cytometry or next-generation sequencing
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate organ function with creatinine clearance 50 mL/min, AST and ALT 2.5 times upper limit of normal, and bilirubin 1.5 times upper limit of normal
- At least 2 weeks since major surgery or radiation therapy
- Completed wash-out period of 4 half-lives if participated in prior investigational trials
- Signed informed consent approved by ethics committee
- Females of childbearing potential using effective contraception during treatment and for at least 8 months after last dose
- Males with female partners of reproductive potential using effective contraception during treatment and for at least 5 months after last dose
- Female patients not of childbearing potential confirmed by hysterectomy, bilateral oophorectomy, ovarian failure, or post-menopausal status
- Willing and able to comply with scheduled visits, treatment plan, lab tests, and study procedures
You will not qualify if you...
- Active central nervous system leukemia
- Active or chronic hepatitis B or C infection, or known HIV positivity unless viral load is undetectable
- Major surgery within less than 2 weeks before randomization
- Unstable or severe uncontrolled medical conditions such as unstable cardiac or pulmonary function
- Concurrent active malignancy except certain treated cancers or those disease free for 2 years
- Uncontrolled cardiac disease
- Pregnant or breastfeeding females, or those not using highly effective contraception as required
- Participation in other investigational studies during active treatment phase
- Other severe acute or chronic medical or psychiatric conditions or lab abnormalities that increase risk or interfere with study participation or results
AI-Screening
AI-Powered Screening
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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
CONTACT
W
Wendy Stock, MD
CONTACT
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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