What is the mechanism of action of this treatment?

Common treatments for blood cancers, such as ibrutinib, work by targeting specific enzymes and pathways crucial for the survival and proliferation of malignant cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, blocks the BTK enzyme, disrupting the B-cell receptor signaling pathway and leading to cancer cell death. Investigational drugs like ABBV-101 for NHL and CLL likely target similar pathways to inhibit cancer growth. Understanding these mechanisms is essential for blood cancer patients as it allows for the selection of targeted therapies that can effectively manage the disease with potentially fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for blood cancers like CLL and NHL, including drugs such as ibrutinib, venetoclax, and monoclonal antibodies, have several known side effects. Ibrutinib can cause bleeding, infections, and cardiovascular issues such as atrial fibrillation and hypertension. Venetoclax is associated with risks of tumor lysis syndrome, neutropenia, and gastrointestinal issues. Monoclonal antibodies, like rituximab, can lead to infusion reactions, infections, and cytopenias. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several FDA-approved drugs are used for the treatment of blood cancers such as non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Venetoclax, a BCL-2 inhibitor, is approved for CLL and small lymphocytic lymphoma (SLL) and is often used in combination with other agents like obinutuzumab. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, is approved for CLL, SLL, and various forms of NHL, including mantle cell lymphoma. Rituximab, a monoclonal antibody targeting CD20, is widely used in the treatment of NHL and CLL. These drugs share similarities with ABBV-101, an investigational drug for NHL and CLL, in terms of targeting specific pathways involved in cancer cell survival and proliferation.

What other types of research exist?

Promising novel alternatives to ABBV-101 for blood cancer patients include: 1) Ibrutinib, a Bruton tyrosine kinase (BTK) inhibitor, which has shown efficacy in CLL and NHL. 2) Venetoclax, a Bcl-2 inhibitor, effective in CLL, especially in patients with 17p deletion. 3) Acalabrutinib, another BTK inhibitor, used in frontline treatment for CLL. 4) Combination therapies such as Ibrutinib plus Venetoclax, which have demonstrated significant results in CLL. 5) Obinutuzumab, a monoclonal antibody, used in combination with other agents for CLL and NHL.

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Monoclonal Antibodies

ABBV-101 for Blood Cancers

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Follicular lymphoma [FL] (grades 1-3b)

Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.

Must not have

Previously treated with a Bruton's tyrosine kinase (BTK) degrader.

Known active CNS disease, or primary CNS lymphoma.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately two years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ABBV-101, a new drug for treating certain blood cancers, in adults who haven't responded to other treatments. It aims to find the safest dose and check if the drug can reduce cancer activity.

Who is the study for?

Adults with certain types of blood cancers, including various forms of non-Hodgkin's lymphoma and chronic lymphocytic leukemia that have not responded to previous treatments. Participants should be in a stable health condition with an expected lifespan of at least 12 weeks and must not have active central nervous system disease or uncontrolled infections.

What is being tested?

The trial is testing ABBV-101, an oral medication for B-cell malignancies. It includes two phases: dose escalation to find the maximum tolerated dose and dose expansion to assess changes in disease activity. The study will last about 60 months and involves regular medical assessments.

What are the potential side effects?

Potential side effects are being evaluated but may include typical reactions associated with cancer therapies such as fatigue, digestive issues, blood disorders, immune system impacts, and possibly others depending on individual responses.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with follicular lymphoma.

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I am able to get out of my bed or chair and move around.

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My DLBCL has not responded to CAR-T or HCT, or I am not eligible for these treatments.

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I have been diagnosed with marginal zone lymphoma.

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My condition is transformed from a slow-growing to a more aggressive non-Hodgkin's lymphoma.

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I have chronic lymphocytic leukemia.

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I have been diagnosed with small lymphocytic lymphoma.

Exclusion Criteria

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

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I have been treated with a BTK degrader before.

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I do not have active brain disease or primary brain lymphoma.

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I do not have an uncontrolled infection or active hepatitis B/C, HIV, or cytomegalovirus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately two years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Electrocardiogram (ECG)

Change in Laboratory Parameters

Change in Vital Signs

+1 more

Secondary study objectives

Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101

Duration of Response (DOR)

Maximum Observed Serum Concentration (Cmax) of ABBV-101

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion ABBV-101 R/R non-GCB DLBCLExperimental Treatment1 Intervention

Participants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Group II: Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)Experimental Treatment1 Intervention

Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Group III: Dose Escalation ABBV-101Experimental Treatment1 Intervention

Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 60 month study duration.

0 / 10Eligibility 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 blood cancers, such as ibrutinib, work by targeting specific enzymes and pathways crucial for the survival and proliferation of malignant cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, blocks the BTK enzyme, disrupting the B-cell receptor signaling pathway and leading to cancer cell death. Investigational drugs like ABBV-101 for NHL and CLL likely target similar pathways to inhibit cancer growth. Understanding these mechanisms is essential for blood cancer patients as it allows for the selection of targeted therapies that can effectively manage the disease with potentially fewer side effects compared to traditional chemotherapy.

Identification of highly potent BTK and JAK3 dual inhibitors with improved activity for the treatment of B-cell lymphoma.A critical appraisal of ibrutinib in the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.Mechanisms of ibrutinib resistance in chronic lymphocytic leukaemia and non-Hodgkin lymphoma.