What side effects are associated with this type of intervention?

Common treatments for Prolymphocytic T-Cell Leukemia (T-PLL) include chemotherapy agents such as procarbazine, lomustine, and vincristine, which are associated with severe hematological toxicities like anemia, neutropenia, and thrombocytopenia. Other frequent adverse events include increased liver enzymes, cutaneous rash, neurotoxicity, and vomiting. Targeted therapies and newer agents like LP-118 may have similar side effects, including cytopenias, gastrointestinal disturbances, and potential neurotoxicity. It is crucial to monitor patients closely for these adverse effects to manage them effectively.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Prolymphocytic T-Cell Leukemia (T-PLL) in the provided context. However, treatments for similar hematologic malignancies often involve targeted therapies, monoclonal antibodies, and chemotherapeutic agents. For instance, chimeric anti-CD4 monoclonal antibodies have shown efficacy in treating mycosis fungoides, a type of cutaneous T-cell lymphoma. Additionally, CAR-T cell therapies targeting CD19 have been approved for other types of refractory lymphomas. These approaches highlight the trend towards targeted and immunomodulatory treatments in hematologic cancers, which may be relevant to the ongoing study of LP-118 for T-PLL.

What other types of research exist?

Promising novel alternatives to LP-118 for T-PLL patients include: 1) Alemtuzumab, which has shown activity in lymphoplasmacytic lymphoma and other hematologic malignancies, though it requires careful management of short- and long-term toxicities. 2) Lenalidomide, which has demonstrated efficacy in various lymphomas and myelodysplastic syndromes, with a focus on managing hematologic complications. 3) PI3K inhibitors like Copanlisib, which have shown promise in relapsed or refractory lymphomas, offering a targeted approach with manageable safety profiles.

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LP-118 for Leukemia

Phase 1

Recruiting

Research Sponsored by Newave Pharmaceutical Inc

Eligibility Criteria Checklist

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

Must have

Group 1d: Relapsed or refractory ALL with dexamethasone run-in [5 days, dexamethasone 10mg/m2 (divided BID)]; Or r/r ALL in remission but with detectable MRD (MRD +) by any detection method per institution standard of practice; IT chemo (per institutional SOC) is permitted prior to LP-118 C1D1 dosing, and then concomitantly on treatment if in best interest of the subject; Relapsed or refractory ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and/or tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and failed, or are currently ineligible/intolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and failed. Relapsed or refractory ALL subjects with age between 13 - 18 years and have body weight ≥ 40kg, ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and/or tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and progressed, or are currently ineligible/intolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and progressed;

Must not have

Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: Uncontrolled active systemic infection (bacterial, fungal, viral); Known poorly controlled of human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive); Unexplained fever > 38.5°C within 7 days prior to the first dose of study drug administration (at the discretion of the Investigator, if the fever is considered attributed to the subject's malignancy or an explained infection may be enrolled). Subjects with known and active central nervous system (CNS) involvement at Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 36 cycles (each cycle is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral drug, LP-118, taken regularly in adults with blood cancers that have returned or resisted other treatments. It aims to find the safest and most effective dose and see if it helps control the cancer.

Who is the study for?

Adults with various advanced blood cancers like CLL, SLL, ALL, AML, and others who have tried at least one or two prior treatments without success can join this trial. It's also open to certain adolescents (13-18) with B cell ALL if they weigh over 40 kg. Participants need good heart function and adequate bone marrow, liver, and kidney function.

What is being tested?

LP-118 is an oral medication being tested in a Phase 1 clinical trial for safety and how the body processes it. The study has two parts: first finding the right dose (Phase 1a), then giving that dose to more people to learn more about its effects (Phase 1b).

What are the potential side effects?

Since LP-118 is new and this is a Phase 1 trial designed to assess safety, specific side effects are not yet fully known but may include typical reactions related to cancer medications such as fatigue, digestive issues or changes in blood counts.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have ALL that has come back or didn't respond to treatment, and I've tried at least two (or one for T cell) previous therapies.

Exclusion Criteria

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

Select...

I do not have uncontrolled infections, HIV, hepatitis B or C, or a recent unexplained fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 36 cycles (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 36 cycles (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 36 cycles (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D) or Optimal Biological Dose (OBD)

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Progression-Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion PhaseExperimental Treatment1 Intervention

Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups. One or more RP2D may be explored. Definition of these cohorts will be accomplished by protocol amendment, and in light of emerging data from Phase 1a.

Group II: Dose Escalation PhaseExperimental Treatment1 Intervention

Phase 1a dose-escalation will begin with group 1 and proceed until DLT is observed and MTD is established, or until an RP2D is established. Subjects enrolled in the dose cohorts will follow the 3+3 study design, starting with an accelerated step-up dosing schedule (with a starting dose of 20 mg, 50 mg, 100 mg once daily) until they reach the designated target dose (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg). Once the MTD or RP2D is established for group 1, the phase 1a dose escalation can proceed for group 2. The starting dose level for group 2 will be one dose level below the MTD or RP2D established for group 1.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Prolymphocytic T-Cell Leukemia (T-PLL) include targeted therapies, immunotherapy, and chemotherapy. Targeted therapies, such as JAK2 inhibitors, aim to block specific pathways that cancer cells use to grow and divide. Immunotherapies, including monoclonal antibodies, work by marking cancer cells for destruction by the immune system. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. These treatments are essential for T-PLL patients as they offer tailored approaches to inhibit cancer progression and improve survival rates while managing side effects.

Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin.Effects of interleukin-3 on myelosuppression induced by chemotherapy for ovarian cancer and small cell undifferentiated tumours.Chemotherapy and neutropenia.