What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, including chemotherapy and targeted therapies, often result in side effects such as hematologic toxicities (neutropenia, anemia, thrombocytopenia), gastrointestinal issues (nausea, vomiting, diarrhea), fatigue, and increased risk of infections. Targeted therapies may also cause specific side effects like skin reactions, hypertension, and infusion-related reactions.

What prior FDA approvals exist?

FDA-approved treatments for Non-Hodgkin's Lymphoma include monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab, which target CD20 on B-cells. Chemotherapy regimens like bendamustine combined with rituximab (BR) are also commonly used. Additionally, targeted therapies such as idelalisib, which inhibits PI3K delta, have shown efficacy in treating NHL. These treatments aim to target specific pathways or markers on lymphoma cells to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to PCLX-001 for Non-Hodgkin's Lymphoma patients include: 1. Ibrutinib - a Bruton's tyrosine kinase (BTK) inhibitor. 2. Acalabrutinib - another BTK inhibitor with a more selective profile. 3. Venetoclax - a BCL-2 inhibitor. 4. Chimeric Antigen Receptor (CAR) T-cell therapy - a personalized immunotherapy approach. These therapies have demonstrated significant efficacy and are part of the evolving landscape of NHL treatment.

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PCLX-001 for Lymphoma and Cancer

Phase 1

Recruiting

Led By Randeep Sangha

Research Sponsored by Pacylex Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Adequate cardiac function per institutional normal measured by echocardiography or multigated acquisition (MUGA) scan (LVEF ≥ 50%)

Participants with histologically-confirmed advanced solid tumor who have failed at least one prior therapy and/or are not eligible for therapies expected to provide clinical benefit.

Must not have

Infections of CTCAE Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade > 2

Acute toxic effects (CTCAE Grade ≥2) of previous anticancer chemotherapy or immunotherapy that have not yet stabilized or if significant post-treatment toxicities have been observed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral medicine called PCLX-001. It focuses on patients with certain advanced cancers and difficult-to-treat B-cell lymphomas. The medicine works by targeting and stopping the growth of cancer cells.

Who is the study for?

Adults with certain advanced cancers (like B-cell lymphomas and solid tumors) who've tried at least one other treatment without success are eligible for this trial. They should have a life expectancy of over 12 weeks, be able to perform daily activities with minimal assistance (ECOG status 0-1), and have organs functioning well enough to meet specific medical tests. Pregnant women can't join, and participants must agree to use contraception.

What is being tested?

The trial is testing PCLX-001, an oral drug, in two parts: dose escalation to find the safe amount that can be given, followed by expansion cohorts where more patients receive this determined dose. It's open-label meaning everyone knows what treatment they're getting; it's not randomized or controlled against another treatment.

What are the potential side effects?

As a Phase I trial primarily assesses safety and tolerability, potential side effects of PCLX-001 aren't fully known yet but may include typical reactions related to cancer drugs such as nausea, fatigue, liver issues or changes in blood counts leading to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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My heart functions well, confirmed by a heart scan.

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I have an advanced solid tumor and previous treatments didn’t work or I can't receive beneficial therapies.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am fully active or can carry out light work.

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I have B-cell lymphoma, failed two treatments, or can't have beneficial therapy.

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My liver is functioning well according to recent tests.

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My kidney function is good, with an eGFR over 50 mL/min or creatinine ≤ 1.5 times the normal upper limit.

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I have advanced cancer and previous treatments didn’t work or I can't receive beneficial therapies.

Exclusion Criteria

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

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I do not have serious infections or those not responding to treatment.

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I am experiencing significant side effects from previous cancer treatments that have not yet stabilized.

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I have or had brain lymphoma.

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I do not have serious heart problems like recent heart attacks or unstable chest pain.

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I haven't had a serious bleeding problem in the last month.

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I am taking a high dose of steroids daily.

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My liver function is significantly impaired.

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I am currently being treated for active hepatitis B or C.

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I have a serious wound or fracture that is not healing.

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I cannot swallow pills.

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I am on medication for uncontrolled seizures.

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I have a condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length 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

To determine the maximum plasma level (Cmax) of PCLX-001

Plasma

To determine, during the dose escalation phase, the recommended dose of PCLX-001 for the dose expansion phase of the trial.

Secondary study objectives

To evaluate the clinical response rate in patients treated with PCLX-001 with advanced solid malignancies

Other study objectives

Assess the pharmacodynamic (PD) effects of PCLX-001 in patients with B-cell lymphomas

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: PCLX-001 interventionExperimental Treatment1 Intervention

The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level. Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle.

0 / 20Eligibility 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 Non-Hodgkin's Lymphoma (NHL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as BTK inhibitors and BCL2 inhibitors, focus on specific molecular pathways essential for lymphoma cell survival and proliferation, offering a more precise treatment with potentially fewer side effects. Immunotherapy, including monoclonal antibodies like rituximab, boosts the immune system's ability to recognize and destroy cancer cells. These mechanisms are important for NHL patients as they provide multiple strategies to combat the disease, potentially improving outcomes and allowing for more personalized treatment approaches.