What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) that target specific pathways, such as BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib) and BCL2 inhibitors (venetoclax), often cause side effects including infections, cytopenias (neutropenia, anemia, thrombocytopenia), gastrointestinal issues (nausea, diarrhea), cardiovascular events (hypertension, atrial fibrillation), and infusion-related reactions. Specific side effects can also include pneumonitis with BTK inhibitors and tumor lysis syndrome with venetoclax.

What prior FDA approvals exist?

Several FDA-approved treatments for Chronic Lymphocytic Leukemia (CLL) target specific pathways in cancer cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has been approved for both newly diagnosed and relapsed CLL, demonstrating benefits in overall and progression-free survival. Acalabrutinib, another BTK inhibitor, is approved for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and has shown efficacy in relapsed CLL. Venetoclax, a BCL-2 inhibitor, combined with obinutuzumab, is also approved for previously untreated CLL, offering higher overall response rates and progression-free survival compared to traditional therapies. These treatments, like CYT-0851, represent advancements in targeting specific molecular pathways in CLL.

What other types of research exist?

Promising novel alternatives to CYT-0851 for Chronic Lymphocytic Leukemia (CLL) patients in 2024 include Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, as well as the BCL2 inhibitor venetoclax, particularly when used in combination with monoclonal antibodies like obinutuzumab.

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Small Molecule Inhibitor

CYT-0851 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Cyteir Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative serum pregnancy test at most 30 days before enrollment and within 72 hours before the first administration of CYT-0851

ECOG Performance Status of 0-1

Must not have

Known history of HIV

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 1: 12 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug called CYT-0851 in patients with certain types of cancer that have not responded to other treatments. The goal is to see if the drug is safe and understand how it works in the body.

Who is the study for?

Adults with certain B-cell malignancies or advanced solid tumors who understand the study and consent to participate. They must have a specific type of tumor, measurable disease, be in good physical condition (ECOG 0-1), and agree to use contraception if necessary. Excluded are those unable to swallow pills, recent heart attack or stroke victims, uncontrolled hypertension sufferers, individuals with active CNS metastases or significant health issues that could affect safety.

What is being tested?

The trial is testing CYT-0851 alone and combined with other chemotherapy drugs like rituximab and bendamustine or gemcitabine in patients with relapsed/refractory B-cell malignancies and advanced solid tumors. The goal is to determine safe dosages for Phase 2 trials.

What are the potential side effects?

Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, risk of infection due to lowered white blood cell counts, possible organ inflammation from drug interactions, and any unique adverse events related to CYT-0851 which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant, breastfeeding, and have a recent negative pregnancy test.

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I am fully active or can carry out light work.

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My cancer is a type of B cell malignancy confirmed by testing.

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My cancer is confirmed by lab tests and meets certain criteria.

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My recent tests show positive biomarkers.

Exclusion Criteria

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

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I have been diagnosed with HIV.

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My high blood pressure is not under control.

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I have a history of lung scarring or fibrosis.

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I have ongoing lung inflammation.

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I have severe nerve pain or damage.

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I have active cancer spread to my brain or spinal cord.

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My cancer has spread to the lining of my brain or spinal cord.

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I have serious vision problems due to cataracts.

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I had a bowel blockage treated medically within the last month.

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I cannot eat two full meals a day or swallow pills.

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I need fluid removed from my abdomen more often than every 4 weeks.

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I have lost more than 10% of my weight in the last 3 months.

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I have had a stem cell transplant from a donor.

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I haven't had cancer treatment in the last 14 days.

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I am taking medication that can affect my heart's rhythm.

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I am on a daily steroid treatment not for cancer, equivalent to more than 10mg of Prednisone.

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I cannot commit to all the study visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 1: 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 1: 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1: 12 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

Part A: Incidence of dose limiting toxicity

Part B: Objective response rate

Part C: Incidence of dose limiting toxicity

+2 more

Secondary study objectives

Part A: Assessment of pharmacokinetic parameters

Part A: Incidence of adverse events and other safety measures

Part A: Objective response rate

+15 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: CYT-0851 dose expansionExperimental Treatment1 Intervention

Part B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles

Group II: CYT-0851 dose escalationExperimental Treatment1 Intervention

Part A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles

Group III: CYT-0851 and rituximab and bendamustineExperimental Treatment2 Interventions

Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle

Group IV: CYT-0851 and gemcitabineExperimental Treatment2 Interventions

Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle

Group V: CYT-0851 and capecitabineExperimental Treatment2 Interventions

Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle

0 / 22Eligibility 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 Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib, acalabrutinib), BCL2 inhibitors (e.g., venetoclax), and monoclonal antibodies (e.g., rituximab, obinutuzumab). BTK inhibitors block the BTK enzyme, which is crucial for B-cell receptor signaling, thereby inhibiting the growth and survival of CLL cells. BCL2 inhibitors promote apoptosis in CLL cells by targeting the BCL2 protein, which prevents programmed cell death. Monoclonal antibodies bind to specific antigens on the surface of CLL cells, marking them for destruction by the immune system. These targeted therapies are significant for CLL patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving both efficacy and quality of life.

Balancing efficacy and toxicity of targeted agents currently used for the treatment of patients with chronic lymphocytic leukemia.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.