LP-118 for Acute Lymphoblastic Leukemia

Not yet recruiting at 1 trial location
DA
Overseen ByDianna Auman, RN
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Wake Forest University Health Sciences
Must be taking: Ponatinib, Dexamethasone, Methotrexate, Blinatumomab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LP-118, to determine its safety and effectiveness in treating Philadelphia chromosome-positive B cell acute lymphoblastic leukemia (ALL). The trial combines LP-118 with standard treatments such as ponatinib, dexamethasone, methotrexate, and blinatumomab. Individuals with newly diagnosed CD19-positive Philadelphia chromosome-positive ALL who can take oral medications might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications for the trial?

The trial requires that any prior treatment for acute lymphoblastic leukemia (ALL) must be stopped at least 24 hours before starting the study therapy. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that LP-118 is likely to be safe for humans?

Research has shown that LP-118, when combined with ponatinib and other cancer drugs, might be safe for certain blood cancers. Studies have found that LP-118 can be used with ponatinib, vincristine, and dexamethasone without major safety issues. These studies aim to determine the safest dose of LP-118 and identify any side effects.

In these trials, researchers carefully assess how well participants tolerate the treatment. The goal is to ensure there are no serious unexpected reactions before proceeding. Although LP-118 remains in the early testing stages, it appears to be well-tolerated.12345

Why do researchers think this study treatment might be promising for acute lymphoblastic leukemia?

Researchers are excited about LP-118 because it offers a new approach to treating acute lymphoblastic leukemia (ALL). Unlike traditional treatments, which often include chemotherapy and targeted therapies like imatinib, LP-118 is designed to work in combination with other drugs to potentially enhance effectiveness. One of its unique features is its ability to be administered as a tablet, making it more convenient for patients than some current treatments that require intravenous administration. Additionally, LP-118's dosing flexibility allows it to be tailored to individual patient needs, which could lead to better outcomes and reduced side effects.

What evidence suggests that LP-118 might be an effective treatment for acute lymphoblastic leukemia?

Studies have shown that LP-118 is a promising treatment for certain blood cancers. It blocks a protein called BCL2, which helps cancer cells survive. Research indicates that LP-118 can cause cancer cells to die, even those resistant to treatments like venetoclax. In studies of chronic lymphocytic leukemia, LP-118 stopped cancer cells from growing. Although LP-118 is still under investigation, its ability to target resistant cancer cells makes it an exciting option for leukemia treatment. This trial will test LP-118 in combination with ponatinib, dexamethasone, blinatumomab, and methotrexate to evaluate its effectiveness in treating acute lymphoblastic leukemia.12346

Who Is on the Research Team?

MB

Madelyn Burkart, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults who have just been diagnosed with a type of leukemia called Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL).

Inclusion Criteria

I am 18 years old or older.
Individuals of childbearing potential must have a negative serum pregnancy test and be surgically infertile or postmenopausal to be exempt
ICBP must use two forms of contraception including one barrier and one highly effective method from consent until 6 months after treatment discontinuation; male participants with female partners must agree to contraception during and 6 months post-treatment
See 9 more

Exclusion Criteria

Unstable or severe uncontrolled medical condition as judged by investigator including unstable cardiac or pulmonary conditions or uncontrolled infection
Women who are pregnant, nursing, or planning pregnancy during study and for 6 months after last treatment; breastfeeding must be discontinued if treated with ponatinib, blinatumomab, and methotrexate due to teratogenic and infant risk
I have not had treatment for ALL, except for short-term or limited approved medicines.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LP-118 in combination with ponatinib, dexamethasone, methotrexate, and blinatumomab. LP-118 dosing is adjusted to determine the maximum tolerated dose.

21 days for dose escalation
Multiple visits for dose monitoring

Follow-up

Participants are monitored for safety, effectiveness, and occurrence of toxicities after treatment

Approximately 3 years
Regular follow-up visits

Long-term follow-up

Participants are monitored for overall survival, relapse-free survival, and event-free survival

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • LP-118

Trial Overview

Researchers are testing if adding a new drug, LP-118, to the usual treatment—ponatinib, dexamethasone, methotrexate, and blinatumomab—is safe and works well for treating this specific kind of leukemia.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Combination of LP-118, ponatinib, dexamethasone, blinatumomab and methotrexateExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Newave Pharmaceutical Inc

Industry Sponsor

Trials
4
Recruited
270+

Atrium Health Wake Forest Baptist

Collaborator

Citations

LP-118 is a novel B-cell lymphoma 2 / extra-large inhibitor that ...

LP-118 is a novel B-cell lymphoma 2 / extra-large inhibitor that demonstrates efficacy in models of venetoclax-resistant chronic lymphocytic leukemia.

NCT06207123 | A Study to Investigate LP-118, Ponatinib ...

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 ...

A drug, LP-118, to treat blood cancer that has come back ...

To find out:The highest dose of LP-118 that's safe to giveIf LP-118 is safe and works well to treat blood cancer that has relapsed or is refractory.

LP-118 in Combination with Ponatinib, Vincristine and ...

LP-118 and ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vincristine is in a class of medications called ...

LP-118 Combination Therapy for Lymphoblastic Leukemia- ...

This trial explores the effectiveness of an experimental drug, LP-118, in combination with an existing drug, ponatinib, for treating T-lineage acute ...

A Study to Investigate LP-118, Ponatinib, Vincristine and ...

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 ...