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Corticosteroid

LP-118 Combination Therapy for Lymphoblastic Leukemia-Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma

18 years old or older

Must not have

Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.

Uncontrolled cardiac disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is being conducted to gather more information about an experimental drug called LP-118 and its potential side effects. The goal is to determine the appropriate dosage of LP-118 and assess if it can

Who is the study for?

This trial is for individuals with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL), including various types of non-Hodgkin's lymphoma and leukemia. Participants must have previously undergone treatment without success.

What is being tested?

The study tests LP-118, an experimental drug, in combination with ponatinib, which is already approved for ALL treatment. It also includes vincristine, dexamethasone, and methotrexate to evaluate safety and determine the proper doses.

What are the potential side effects?

Potential side effects may include reactions specific to LP-118 which are under investigation. Common side effects of chemotherapy like ponatinib might involve fatigue, nausea, hair loss, increased infection risk, bleeding complications, and liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia or lymphoma has returned or didn't respond to treatment.

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I am 18 years old or older.

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I have had a hysterectomy, my ovaries removed, or I am confirmed to be post-menopausal.

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My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.

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I had major surgery or radiation therapy at least 2 weeks ago and have recovered from any serious side effects.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe uncontrolled health issues like heart or lung problems.

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I have a heart condition that is not well-managed.

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My leukemia has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended Phase II Dose To demonstrate safety and to identify the recommended phase II dose for combination of LP-118, ponatinib, vincristine and dexamethasone

Secondary study objectives

Complete Clinical Remission (CR) with Measurable Residual Disease (MRD)

Complete Clinical Remission at Days 28 and 56

Complete clinical remission with incomplete count recovery (CRi) at Days 28 and 56

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All Participants (Single Arm)Experimental Treatment5 Interventions

All study participants will receive LP-118 and ponatinib. The initial dose of LP-118 to be tested is 100 mg, and initial dose of ponatinib to be tested is 30 mg. Higher doses of LP-118 will only be tested if the study doctor feels it is safe to do so. A member of the study team will let study participants know which doses they are assigned. Study drugs will be given in 21-day cycles. There will be 7 study visits in cycle 1 (on Days 1, 5, 6, 7, 15, 22, and 28). LP-118 and ponatinib will be taken at home every day. Dexamethasone will be taken between days 1-7 and days 15-22. For Cycles 2-12, study participants will have 5 study visits per cycle (on Days 1, 8, 15, 22, and 28). On all days, study participants will take LP-118 and ponatinib at home. Participants in this group will also receive standard of care vincristine, dexamethasone, and methotrexate during study cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ponatinib

2015

Completed Phase 2

~830

Dexamethasone

2007

Completed Phase 4

~2650