← Back to Search

Kinase Inhibitor

Acalabrutinib + Obinutuzumab + Glofitamab for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By John H Baird

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Age: >= 18 years

Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification

Must not have

Prior exposure to a BTK inhibitor (including but not limited to ibrutinib, ac

Prior treatment with a T-cell engaging bispecific antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combo of drugs to treat relapsed/refractory mantle cell lymphoma. It may help the body's immune system attack cancer and stop cancer cells from growing.

Who is the study for?

This trial is for adults with mantle cell lymphoma that has returned or didn't respond to previous treatments. Participants must be in fairly good health, have a certain level of blood counts and organ function, and agree to use effective birth control. People can't join if they've had certain recent cancer treatments, used T-cell engaging bispecific antibodies before, or been exposed to BTK inhibitors like ibrutinib.

What is being tested?

The trial tests the combination of acalabrutinib (a kinase inhibitor), obinutuzumab (a monoclonal antibody), and glofitamab (a bispecific antibody) on patients with relapsed/refractory mantle cell lymphoma. It aims to see how well these drugs work together and what side effects they might cause.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as infusion reactions, low blood counts leading to increased infection risk or bleeding problems, liver enzyme changes suggesting liver impact, fatigue, and possibly heart issues due to the stress on the body's systems.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

My lymphoma is confirmed as mantle cell type.

Select...

My white blood cell count is healthy, or I have bone marrow involvement.

Select...

My kidney function, measured by creatinine levels or clearance, is normal.

Select...

My tumor is CD20 positive after my latest treatment.

Select...

My platelet count is above 75,000/mm^3 without bone marrow involvement or above 30,000/mm^3 with it.

Select...

My condition worsened or didn't improve after at least one treatment.

Select...

I have recovered from side effects of cancer treatment, except for hair loss.

Select...

I am a woman who can have children and my pregnancy test is negative.

Select...

My blood clotting measurements are within safe limits.

Select...

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

Select...

My hemoglobin level is at least 8 g/dL, unless it's low because of my illness.

Exclusion Criteria

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

Select...

I have previously been treated with a BTK inhibitor.

Select...

I have been treated with a bispecific antibody before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years from start of treatment 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 (phase 2)

Incidence of unacceptable adverse events (AEs) (safety lead-in)

Secondary study objectives

Duration of response

Incidence of AEs

Minimal residual disease (MRD) negatively rate

+4 more

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, glofitamab)Experimental Treatment9 Interventions

Patients recieve acalabrutinib PO BID of each cycle, obinutuzumab IV on days 1 and 7 of cycle 1 only, and glofitamab IV over 2-4 hours on days 8 and 15 of cycle 1 and day 1 of each subsequent cycle. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with MRD positive CR, PR, or SD after 12 cycles of protocol therapy may continue receiving single agent acalabrutinib per standard of care during the follow-up phase of the study. Patients also undergo a ECHO or MUGA during screening, as well as PET/CT or CT, and blood specimen collection throughout the trial. Patients may also undergo bone marrow biopsies throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glofitamab

2021

Completed Phase 1

~60

Computed Tomography

2017

Completed Phase 2

~2740