What side effects are associated with this type of intervention?

Common treatments for lymphoproliferative disorders include enzyme inhibitors like acalabrutinib and immunotherapies such as obinutuzumab. Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, is generally well-tolerated but can cause side effects such as headache, diarrhea, and increased risk of infections. Obinutuzumab, an anti-CD20 monoclonal antibody, can lead to infusion-related reactions, neutropenia, and infections. Both treatments aim to inhibit cancer cell growth and enhance the immune system's ability to target cancer cells, but they come with risks of immune-related adverse events and hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of lymphoproliferative disorders that are similar to those being studied in the trial involving acalabrutinib and obinutuzumab. Acalabrutinib, a BTK inhibitor, has been approved for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Obinutuzumab, an anti-CD20 monoclonal antibody, has been approved for use in combination with chlorambucil for the treatment of CLL and in combination with bendamustine for follicular lymphoma. These approvals highlight the effectiveness of enzyme inhibition and immunotherapy in managing lymphoproliferative disorders.

What other types of research exist?

Promising novel alternatives for lymphoproliferative disorders include IBI301 plus CHOP, which has shown non-inferiority efficacy and comparable safety to Rituximab plus CHOP in untreated diffuse large B-cell lymphoma (DLBCL). Additionally, fixed-duration Ibrutinib-Venetoclax has demonstrated efficacy in chronic lymphocytic leukemia (CLL) and comorbidities. These alternatives offer potential new treatment options for patients in 2024.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Obinutuzumab for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Jonathon B Cohen, MD, MS

Research Sponsored by Emory University

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies acalabrutinib and obinutuzumab in patients with certain types of untreated lymphoma. Acalabrutinib blocks enzymes needed by cancer cells, while obinutuzumab helps the immune system fight these cells. The goal is to see if this combination can effectively kill more cancer cells.

Who is the study for?

This trial is for adults with untreated follicular lymphoma or other indolent non-Hodgkin lymphomas. Participants must be willing to use contraception, have no active high-grade cancers, and not require certain medications that could interfere with the study drugs. They should not have major health issues like uncontrolled autoimmune diseases, significant infections within 14 days before starting the trial, or a history of severe allergic reactions to similar drugs.

What is being tested?

The trial is testing acalabrutinib combined with obinutuzumab in patients who haven't been treated before for their lymphoma. Acalabrutinib targets enzymes needed by cancer cells to grow while obinutuzumab works by helping the immune system affect cancer cell growth and spread.

What are the potential side effects?

Potential side effects include allergic reactions to medication components, liver enzyme elevations, bleeding complications, digestive tract ulcers within three months prior to screening, and possible interference with oral medication absorption due to gastrointestinal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Complete response (CR) rate

Incidence of grade 3+ adverse events

Secondary study objectives

2-year progression free survival (PFS)

CR rate for acalabrutinib monotherapy at end of single-agent run-in

Duration of response (DOR)

+5 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

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: Treatment (acalabrutinib, obinutuzumab)Experimental Treatment4 Interventions

INDUCTION PHASE: Patients receive acalabrutinib PO BID on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 3, then on day 1 of cycles 4-8. Treatments repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. FOLLOW-UP PHASE: After cycle 12, patients who are in CR are randomized to either discontinue acalabrutinib or to continue acalabrutinib monotherapy in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after cycle 12 continue acalabrutinib monotherapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression after cycle 12 discontinue study treatment. Patients with disease progression at any time prior to the conclusion of cycle 12 may continue study therapy if they are felt to be benefiting by the treating physician, but not past cycle 12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Obinutuzumab

2014

Completed Phase 3

~3470

Do I qualify?Apply below to find out

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

Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, blocks the BTK enzyme essential for B-cell receptor signaling, thereby inhibiting the growth and survival of malignant B cells. Obinutuzumab, an anti-CD20 monoclonal antibody, targets the CD20 protein on B cells, leading to their destruction through immune-mediated mechanisms. These targeted approaches are crucial for lymphoproliferative disorder patients as they offer more effective and tailored treatments with specific safety profiles, improving therapeutic outcomes.

Acalabrutinib: A Selective Bruton Tyrosine Kinase Inhibitor for the Treatment of B-Cell Malignancies.A critical appraisal of ibrutinib in the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.