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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years from start of treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am 18 years old or older.

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My lymphoma is confirmed as mantle cell type.

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

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

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My tumor is CD20 positive after my latest treatment.

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

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

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

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

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My blood clotting measurements are within safe limits.

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete response (CR) rate (phase 2)

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

Secondary outcome measures

Duration of response

Incidence of AEs

Minimal residual disease (MRD) negatively rate

+4 more

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

~2720

Acalabrutinib

2020

Completed Phase 2

~2050

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Biospecimen Collection

2004

Completed Phase 2

~1700

Echocardiography

2013

Completed Phase 4

~11670

Obinutuzumab

2015

Completed Phase 3

~3250

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,620 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,669 Previous Clinical Trials

40,926,281 Total Patients Enrolled

John H BairdPrincipal InvestigatorCity of Hope Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration granted clearance for acalabrutinib, obinutuzumab, glofitamab as treatments?

"Based on the gathered evidence, our team graded Treatment (acalabrutinib, obinutuzumab, glofitamab) with a 2. This is due to its Phase 2 status which suggests that safety has been established but efficacy still needs to be proven."

Answered by AI

Are candidates still being accepted to participate in this study?

"According to clinicaltrials.gov, this trial has ceased recruiting efforts after first being posted on October 10th 2023 and lastly updated on September 20th of the same year. Despite not actively seeking participants at present, 1724 other medical studies are currently looking for candidates."

Answered by AI

What is the ultimate target outcome of this trial?

"The primary measure of success in this trial, assessed over the initial two 21-day cycles, is to observe a complete response rate (CR) as part of phase 2. Secondary objectives include measuring time to response, duration of response and progression-free survival using Kaplan and Meier estimations with 95% confidence intervals based on log-log transformations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

2024. "Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054776.

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