What side effects are associated with this type of intervention?

Common treatments for relapsed or refractory Follicular Lymphoma, such as chemoimmunotherapy regimens (e.g., bendamustine plus rituximab) and bispecific antibodies (e.g., odronextamab), often have side effects including neutropenia, anemia, lymphopenia, hypophosphatemia, nausea, fatigue, and cytokine release syndrome. These treatments can also cause neurological adverse events, although these are typically low grade and do not usually result in treatment discontinuation.

What prior FDA approvals exist?

The FDA has approved several treatments for relapsed or refractory follicular lymphoma, including monoclonal antibodies like rituximab and obinutuzumab, often used in combination with chemotherapy. Chemoimmunotherapy regimens such as bendamustine plus rituximab (BR) have shown efficacy. Additionally, novel agents like lenalidomide in combination with rituximab (R^2 regimen) and PI3K inhibitors such as copanlisib have been approved for this indication. These treatments share similarities with ABBV-319, which is also being investigated for its efficacy in relapsed or refractory B-cell lymphomas.

What other types of research exist?

Promising novel alternatives to ABBV-319 for Follicular Lymphoma patients include: 1) Venetoclax plus Rituximab, which has shown efficacy in relapsed/refractory FL in the CONTRALTO study. 2) BTK inhibitors such as Ibrutinib or Acalabrutinib, which are used in combination with other agents like Obinutuzumab. 3) CAR T-cell therapies, which are emerging as a potent option for relapsed/refractory FL. These alternatives offer different mechanisms of action and have demonstrated promising results in clinical trials.

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Monoclonal Antibodies

ABBV-319 for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ABBV-319 for adults with certain blood cancers that have come back or didn't respond to treatment. The drug is given in regular intervals, starting with small amounts and gradually increasing to find the most effective amount. The goal is to see if ABBV-319 is safe and effective in reducing cancer activity.

Who is the study for?

Adults with certain types of blood cancers (DLBCL, FL, or CLL) that have come back or didn't respond to treatment can join. They must be in good physical condition (ECOG 0-1), meet specific lab value criteria, and have measurable disease. Those who've had CD19-targeting therapy need a recent biopsy. People with active infections, uncontrolled conditions, or CNS lymphoma cannot participate.

What is being tested?

The trial is testing ABBV-319's safety and how it affects the body when given through an IV to adults with relapsed/refractory B-cell lymphomas. It includes two phases: finding the best dose and then seeing how well it works at that dose across multiple sites worldwide.

What are the potential side effects?

Potential side effects are not specified but will be monitored throughout the study via medical assessments and blood tests. Side effects could include typical reactions to cancer treatments such as fatigue, nausea, infusion-related reactions, and changes in blood counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 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

Antidrug Antibody (ADA)

Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319

Maximum Observed Serum Concentration (Cmax) of ABBV-319

+4 more

Secondary study objectives

Duration of Response (DOR)

Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria

Overall survival (OS) Time

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Escalation ABBV-319Experimental Treatment1 Intervention

Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose (RP2D) is determined.

Group II: (ABBV-319) Follicular Lymphoma (FL) ParticipantsExperimental Treatment1 Intervention

Participants with R/R FL will receive ABBV-319 in 21-day cycles.

Group III: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) ParticipantsExperimental Treatment1 Intervention

Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.

Group IV: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) ParticipantsExperimental Treatment1 Intervention

Participants with R/R CLL will receive ABBV-319 in 21-day cycles.

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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 Follicular Lymphoma include monoclonal antibodies like rituximab, which target the CD20 protein on B-cells, and small molecule inhibitors such as ibrutinib and venetoclax, which interfere with B-cell receptor signaling and BCL2 pathways, respectively. These treatments work by specifically targeting cancerous B-cells, thereby reducing tumor burden and improving patient outcomes. Investigational drugs like ABBV-319, which are being studied for relapsed or refractory B-cell lymphomas, aim to enhance these targeted approaches, offering hope for more effective management of the disease.

Treatment patterns and outcomes of patients with relapsed or refractory follicular lymphoma receiving three or more lines of systemic therapy (LEO CReWE): a multicentre cohort study.Treatment of indolent lymphoma.Zevalin: the first radioimmunotherapy approved for the treatment of lymphoma.