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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

Study Summary

This trial is testing a new combination therapy for patients with previously untreated follicular lymphoma or other indolent non-Hodgkin lymphoma.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate
Incidence of grade 3+ adverse events
Secondary outcome measures
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
2%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

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
~2050
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,524 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,853 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,618 Total Patients Enrolled
85 Trials studying Lymphoproliferative Disorders
67,933 Patients Enrolled for Lymphoproliferative Disorders

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04883437 — Phase 2
Lymphoproliferative Disorders Research Study Groups: Treatment (acalabrutinib, obinutuzumab)
Lymphoproliferative Disorders Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04883437 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883437 — Phase 2

Frequently Asked Questions

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

What are the benefits of Acalabrutinib?

"Acalabrutinib not only effectively treats refractory follicular lymphoma, but also renal dysfunction, chronic lymphocytic leukemia (cll), and kidney failure."

Answered by AI

Has Acalabrutinib received federal approval for use?

"There is some clinical data supporting Acalabrutinib's safety, but its efficacy has not yet been explored in trials. It received a score of 2."

Answered by AI

Are there other examples of Acalabrutinib's efficacy?

"Acalabrutinib is being trialled in 198 live clinical studies, 30 of which are in Phase 3. Many of these trials originated from Tampa, Florida, but there are 13407 total locations running these tests."

Answered by AI

How many people are trying out this new medical treatment?

"That is correct, the online clinicaltrial.gov registry indicates that this research is recruiting patients as of December 7th, 2021. The original posting date for the trial was September 3rd, 20201 and 49 individuals are needed from 1 medical facility."

Answered by AI

What are the objectives of this research?

"The primary objective of this clinical trial, as measured over a period of up to 30 days after treatment, is the complete response rate. In addition to the primary outcome, this trial will also assess secondary outcomes including overall survival and quality of life. Overall survival is defined as the duration of time that patients survive after treatment, and will be estimated using Kaplan-Meier methodology. Quality of life assessments are defined as measures of how well patients are able to function during and after treatment, compared to their baseline values at the screening visit. These will be analyzed using paired t-tests, McNemar's tests, or their nonparam"

Answered by AI

Have other researchers looked into this topic before?

"Since first being studied in 2007, Acalabrutinib has had 198 trials conducted across 1433 cities and 55 countries."

Answered by AI

Are patients still being enrolled in this research project?

"This study, which was posted on September 3rd 2021, is currently recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
Jonathon Cohen 2021. "Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04883437.
All > Follicular Lymphoma
~14 spots leftby Apr 2025
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