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Acute LeukemiaPhase 1/2NCT06207123

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)

A Phase 1/2 study testing LP-118, Ponatinib and Vincristine in people with Acute Leukemia and Lymphoblastic Leukemia, run by University of Chicago at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LP-118, Ponatinib and Vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
13 Sep 2024to 1 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (NGS)-based measurable residual disease (ClonoSEQ, Adaptive Technologies). Patients with isolated extramedullary disease that is measurable by computed tomography (CT) scan are also eligible.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • Adequate organ function as defined by all of the following:
  • Creatinine clearance ≥50 mL/min, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.
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  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN) and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e,, leukemic involvement). For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
  • Participants must be at least 2 weeks from major surgery or radiation therapy. A wash-out period of 4 half-lives is required for patients who participated in other investigational trials. These patients must have recovered from clinically significant toxicities related to these prior treatments.
  • Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose. A patient is of childbearing potential if, in the opinion of the treating investigator, he/she is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):
  • Have undergone hysterectomy or bilateral oophorectomy; or have medically confirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).
  • Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Active central nervous system (CNS) leukemia
  • Active or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). Patients with HIV but an undetectable viral load are eligible for enrollment.
  • Major surgery within <2 weeks before randomization.
  • Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.
  • Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.
  • Uncontrolled cardiac disease.
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  • Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.
  • Participation in other investigational studies during active treatment phase.
  • Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Caner Saygin, MD contact

773-834-8982

caner.saygin@bsd.uchicago.edu

Wendy Stock, MD contact

773-834-8982

wstock@bsd.uchicago.edu

United States2 sites, 2 recruiting

  • University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60615

    Caner Saygin, MD, 773-834-8982, caner.saygin@bsd.uchicago.edu

    Recruiting

  • University of Rochester Medical Center, Wilmot Cancer Center

    Rochester, New York, 14642

    Kristen O'Dwyer, MD, 585-275-5863, kristen_odwyer@urmc.rochester.edu

    Wilmot Cancer Center Clinical Trials Office, 585-275-5863, wcictoresearch@urmc.rochester.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory T-ALL/LBL

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.

Read the detailed description

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.

This study will investigate the combination of LP-118 and ponatinib at different dose levels to find the best doses that can be safely given to patients. This means that enrolled subjects will receive progressive increasing or decreasing doses of these drugs until the maximally tolerated dose is determined. All participants will also receive a standard of care chemotherapy combination consisting of the FDA approved drugs vincristine, dexamethasone and intrathecal (injection into the spinal canal, also called "spinal tap") methotrexate. This combination is standard of care for relapsed T-ALL/LBL.

Being tested
LP-118, Ponatinib, Vincristine, Dexamethasone, Methotrexate
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP-118Drug

    LP-118 is an experimental anti-cancer drug that is currently being studied in clinical trials for multiple types of hematological cancers and solid tumors.

  • PonatinibDrug

    Also called Iclusig

    Ponatinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells).

  • VincristineDrug

    Also called Oncovin, Vincrex, Vincasar PES

    Vincristine is a chemotherapy medication used to treat various types of cancer, including leukemia, lymphoma, neuroblastoma, and Wilms tumor. Vincristine belongs to the category of vinca alkaloids, a class of drugs that function by impeding the proper division of cancer cells.

  • DexamethasoneDrug

    Also called DexPak, Decadron

    Dexamethasone is used to treat cancer, to decrease inflammation and sometimes used before and after chemotherapy to prevent or treat nausea and/or vomiting. It is given in the vein (IV) or orally (by mouth)

  • MethotrexateDrug

    Also called Otrexup, Xatmep, Rasuvo

    Methotrexate is a drug used to treat cancer of the blood, bone, lung, breast, head, and neck. It can also treat rheumatoid arthritis and psoriasis.

Study groups in NCT06207123
Study groupRoleWhat they receive
All Participants (Single Arm)ExperimentalAll 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.
Receives: Drug: LP-118; Drug: Ponatinib; Drug: Vincristine; Drug: Dexamethasone; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Recommended phase II dose for combination of LP-118, ponatinib, vincristine and dexamethasone as assessed by rate of dose-limiting toxicities among study participants.

    Measured: 36 weeks

Secondary outcomes (6)

  1. Complete Clinical Remission at Days 28 and 56

    Complete clinical remission at days 28 and 56 for study participants defined as the disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blasts, with recovery of hematopoiesis defined by ANC ≥1000/μL and platelets ≥100,000/μL.

    Measured: 36 weeks

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

    Complete clinical remission with incomplete count recovery (CRi) at day 28 and 56 for study participants treated at the recommended phase 2 (RP2D) dose level, defined as complete clinical remission except with ANC< 1000/μL and/or platelets <100,000/μL

    Measured: 36 weeks

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

    Complete clinical remission with measurable residual disease (MRD) negativity at day 28 and 56 for participants treated at the recommended phase 2 (RP2D) dose level.

    Measured: 36 weeks

  4. Complete clinical remission with incomplete count recovery (CRi) with Measurable Residual Disease (MRD)

    CRi with MRD negativity at days 28 and 56, defined by absence of detectable disease by flow cytometry (sensitivity of 0.01%), and V(D)J next-generation sequencing-based MRD assessment (sensitivity of 0.0001%)

    Measured: 36 weeks

  5. Overall Survival

    Overall survival (OS), defined as the time from treatment administration to death from any cause, or until last contact if the patient has not died.

    Measured: 36 weeks

  6. Progression-Free Survival

    Progression-free survival (PFS), defined as the time from treatment administration to documented disease progression or death from any cause, or until last contact if no event has occurred.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start13 Sep 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207123
Sponsor's protocol ID
IRB23-1382
Status last verified
Mar 2026
First submitted
5 Jan 2024
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LP-118, Ponatinib and Vincristine in people with Acute Leukemia and Lymphoblastic Leukemia, run by University of Chicago at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caner Saygin, MD (773-834-8982, caner.saygin@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose To demonstrate safety and to identify the recommended phase II dose for combination of LP-118, ponatinib, vincristine and dexamethasone (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06207123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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