What side effects are associated with this type of intervention?

Common treatments for lymphoma, such as chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy can cause alopecia, nausea, vomiting, fatigue, and increased risk of infections. Targeted therapies, like antibody-drug conjugates, may lead to hair loss, gastrointestinal issues, and fatigue, with the severity depending on the specific agent used. Immunotherapy, including checkpoint inhibitors, can cause immune-related adverse effects such as colitis, dermatitis, and endocrinopathies. Oral administration of these treatments generally results in fewer severe side effects compared to high-dose intravenous regimens.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of lymphoma. Notable examples include rituximab, an anti-CD20 monoclonal antibody, which is often used in combination with other chemotherapeutic agents like bendamustine. Idelalisib, a PI3K inhibitor, has also been approved for certain types of lymphoma. These treatments focus on targeting specific pathways or markers on cancer cells to inhibit their growth and proliferation. While the exact mechanism of action for CYC140 is not specified, these examples illustrate the types of targeted therapies that have been successfully used in lymphoma treatment.

What other types of research exist?

Promising novel alternatives to CYC140 for lymphoma patients include: 1) MLN4924 (pevonedistat), which induces apoptosis and cell cycle arrest, showing potential in renal cell carcinoma and possibly other cancers. 2) MI130110, an antibody-drug conjugate targeting CD13, demonstrating antitumor activity in specific models. 3) Rituximab-modified AZD-2014-encapsulated nanoparticles, which have shown improved efficacy against B lymphoma cells by blocking mTORC1 and mTORC2. These alternatives offer different mechanisms of action and have shown promising results in preclinical or early clinical studies.

← Back to Search

Other

CYC140 for Advanced Cancers and Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Cyclacel Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

ECOG performance status of 0-2

Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels

Must not have

Presence of an active infection requiring intravenous antibiotics

Subjects who have not received vaccines for severe acute respiratory syndrome-corona virus-2 (SARS-COV-2) and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral drug, CYC140, in patients with advanced cancers who have no other treatment options. It aims to see if the drug is safe and effective in stopping cancer growth or killing cancer cells.

Who is the study for?

Adults (≥18 years) with advanced solid tumors or lymphoma that have worsened after standard therapy, or when no standard treatment is available. They must be able to take oral medication and not have GI issues affecting drug absorption. Participants need a stable health status, confirmed by an ECOG score of 0-2, and agree to use effective birth control.

What is being tested?

The trial is testing CYC140, taken orally daily in two phases: Phase 1 for safety and dosage in various cancers; Phase 2 focuses on effectiveness in specific cancers. It's open-label so everyone knows they're getting the drug, and it measures how the body processes it.

What are the potential side effects?

While specific side effects of CYC140 are not listed here, common ones from similar cancer drugs include nausea, fatigue, risk of infection due to lowered immunity, diarrhea or constipation, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take care of myself and perform daily activities.

Select...

I can swallow pills and don't have major stomach or bowel issues affecting drug absorption.

Select...

My advanced cancer has worsened despite standard treatments, or I can't tolerate them.

Select...

I had a stem cell transplant and don't have active fungal infections or severe graft-versus-host disease.

Exclusion Criteria

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

Select...

I am currently on IV antibiotics for an infection.

Select...

I haven't been vaccinated for COVID-19 and show symptoms or have it confirmed.

Select...

I haven't had cancer treatments or still have side effects within the last 3 weeks.

Select...

I don't have any health or mental conditions that could affect the study.

Select...

I have HIV with an uncontrolled viral load and take medication that could affect metabolism.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I do not have diseases that affect my stomach or intestines' ability to absorb medication.

Select...

I have heart problems or diseases.

Select...

I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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

Overall Response Rate (ORR)

Secondary study objectives

AUC

Adverse events

Cmax

+6 more

Other study objectives

Pharmacodynamics

Pharmacogenomics

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: Phase 2Experimental Treatment1 Intervention

Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles.

Group II: Phase 1 Dose EscalationExperimental Treatment1 Intervention

Phase 1 = CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved.

0 / 13Eligibility 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

Common treatments for lymphoma include chemotherapy, targeted therapies, and immunotherapies. Chemotherapy drugs, such as cyclophosphamide and doxorubicin, work by damaging the DNA of rapidly dividing cells, leading to cell death. Targeted therapies, like Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib) and BCL2 inhibitors (e.g., venetoclax), specifically target molecular pathways crucial for lymphoma cell survival and proliferation. Immunotherapies, including monoclonal antibodies (e.g., rituximab), enhance the immune system's ability to recognize and destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific characteristics of the lymphoma, potentially improving outcomes and minimizing side effects.