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Grade 1 Follicular LymphomaPhase 2NCT04883437

Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas

A Phase 2 study testing Acalabrutinib, Obinutuzumab and Quality-of-Life Assessment in people with Grade 1 Follicular Lymphoma and Grade 2 Follicular Lymphoma, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies the effect of acalabrutinib and obinutuzumab in treating patients with follicular lymphoma or other indolent non-Hodgkin lymphoma for which the patient has not received treatment in the past (previously untreated). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acalabrutinib, Obinutuzumab and Quality-of-Life Assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
3 Sep 2021to 15 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women >= 18 years of age
  • Patients will need to have one of the following clinical scenarios:
  • Previously untreated follicular lymphoma grade 1-3a with low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
  • Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but who are unable or unwilling to receive standard front-line treatment approaches
  • Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or any other indolent B-cell lymphoproliferative disorder with low tumor burden by GELF criteria or who are unable/unwilling to receive more intensive front-line treatment
  • Previously untreated mantle cell lymphoma who would otherwise be appropriate candidates for watchful waiting OR who have symptomatic disease but are not candidates for or decline standard induction approaches
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  • Patients with previously untreated low tumor burden FL (criterion above) must have measurable and/or assessable disease defined as at least one involved lymph node or extranodal disease site that measures >= 1.5cm in greatest diameter
  • Patients who meet inclusion criteria above are eligible as long as they meet one of the following criteria for measurable/assessable disease:
  • At least one involved lymph node or extranodal disease site measuring > 1.5cm in greatest diameter
  • Pathologically-confirmed bone marrow or peripheral blood involvement that can be reassessed for response
  • Pathologically confirmed splenic or extranodal involvement with at least one known site of disease remaining after diagnostic biopsy that can be reassessed (i.e., patients with splenic marginal zone lymphoma who complete splenectomy and have no other detectable disease would not be eligible)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Woman of childbearing potential (WOCBP) and men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab, whichever is longer. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Women of childbearing potential must have a negative serum or urine pregnancy test prior to starting therapy
  • Willing and able to participate in all required evaluations and procedures in this study protocol
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Who cannot join

  • The presence or history of histologically transformed or co-existing high-grade or aggressive non-Hodgkin lymphoma
  • Confirmed active or prior central nervous system disease
  • Prior receipt of lymphoma-directed therapy or prior antibody-based therapy (except for anti-microbial therapy for infection-associated marginal zone lymphoma such as hepatitis C or H pylori)
  • A short course of steroids is permitted for patients aside from those in the low tumor burden FL cohort. This course may be no more than 14 days and steroids must be discontinued (or tapered to =< 10mg prednisone or equivalent) no later than 3 days after initiation of study treatment. Patients in the low tumor burden FL cohort may not receive corticosteroids as an anti-lymphoma therapy at any time before starting treatment
  • Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for >= 2 years or which will not limit survival to < 5 years
  • Clinically significant cardiovascular disease such as symptomatic ventricular arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll on study if deemed appropriate by the investigator
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  • Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
  • Known history of human immunodeficiency (HIV) or any active significant infection (e.g., bacterial, viral, or fungal) within 14 days of cycle 1. Patients with uncomplicated viral or bacterial infections that are being managed with oral antibiotics and/or supportive care alone are eligible
  • Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components
  • Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
  • Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)
  • Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
  • Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with proton pump inhibitors (e.g, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study
  • History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug. Patients with a transient ischemic attack which has resolved and for which there are no ongoing symptoms are eligible
  • Major surgical procedure within 28 days of first dose of study drug (not including a diagnostic procedure to make the lymphoma diagnosis). Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug
  • Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo deoxyribonucleic acid (DNA) PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result to be eligible and have completed appropriate anti-viral treatment. Those who are hepatitis C PCR positive will be excluded. Anti-viral therapy for patients with hepatitis-C associated marginal zone lymphoma will not be considered a prior anti-lymphoma treatment
  • Absolute neutrophil count (ANC) < 1,000/mcL
  • Platelet count < 50,000/mcL (Unless felt to be related to underlying disease)
  • Total bilirubin >= 1.5 x the upper limit of normal (ULN). Isolated bilirubin > 1.5 x ULN is permitted if the direct proportion is < 35%
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN
  • Creatinine clearance =< 40 mL/min/1.73m^2
  • Breastfeeding or pregnant
  • Concurrent participation in another therapeutic clinical trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathon Cohen, MD, MS contact

404-778-2419

jonathon.cohen@emory.edu

United States1 site, 1 recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    David Reagan, 404-251-1275, dreagan@emory.edu

    Jonathon Cohen, MD,MS

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label Phase 2 Trial of Acalabrutinib Plus Obinutuzumab in Patients With Untreated, Low Tumor Burden Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas

This phase II trial studies the effect of acalabrutinib and obinutuzumab in treating patients with follicular lymphoma or other indolent non-Hodgkin lymphoma for which the patient has not received treatment in the past (previously untreated). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and obinutuzumab may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if treatment acalabrutinib and obinutuzumab is effective in patients with untreated, low tumor burden follicular lymphoma and other indolent non-Hodgkin lymphomas (NHLs).

SECONDARY OBJECTIVES:

  1. Determine the complete response (CR) rate for single agent acalabrutinib at the end of a single-agent run-in for patients with untreated low tumor burden follicular lymphoma (FL).

II. Determine tolerability of acalabrutinib and obinutuzumab via assessment of patient-reported outcomes and conventional assessments.

III. Assess duration of response and long-term outcomes including progression-free survival.

IV. Assess the impact of early treatment with this regimen on health-related quality of life.

TERTIARY/EXPLORATORY OBJECTIVES:

  1. Evaluate the impact of treatment discontinuation in patients who have achieved a complete response at the end of the induction phase.

II. To assess the safety and efficacy of acalabrutinib and obinutuzumab in other subtypes of indolent NHL.

OUTLINE:

INDUCTION PHASE: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Patients also receive obinutuzumab intravenously (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 partial response (PR) or stable disease (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.

After completion of study treatment, patients are followed up at 30 days, every 12 weeks for 1 year, then every 6 months until disease progression or next anti-lymphoma treatment.

Being tested
Acalabrutinib, Obinutuzumab, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoproliferative Disorders, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcalabrutinibDrug

    Also called ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196, Calquence

    Given PO

  • ObinutuzumabBiological

    Also called Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04883437
Study groupRoleWhat they receive
Treatment (acalabrutinib, obinutuzumab)ExperimentalINDUCTION 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.
Receives: Drug: Acalabrutinib; Biological: Obinutuzumab; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response (CR) rate

    Complete response rate will be calculated, and a 95% confidence interval will be estimated using the Clopper-Pearson method.

    Measured: Up to start of cycle 6 (each cycle = 28 days)

  2. Incidence of grade 3+ adverse events

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days post treatment

Secondary outcomes (8)

  1. Overall response rate

    Overall response rate will be calculated, and a 95% confidence interval will be estimated using the Clopper-Pearson method.

    Measured: Up to 3 years

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

    Will be calculated, and a 95% confidence interval will be estimated using the Clopper-Pearson method.

    Measured: Up to 3 years

  3. 2-year progression free survival (PFS)

    PFS will be estimated using Kaplan-Meier methodology. Approximate 95% confidence intervals (CIs) for median PFS will be computed using the Brookmeyer and Crowley method.

    Measured: From first dose to documented disease progression, or death from any cause, whichever occurs first, assessed at 2 years

  4. Overall survival (OS)

    Duration of OS will be estimated using Kaplan-Meier methodology. Approximate 95% CIs for median OS will computed using the Brookmeyer and Crowley method.

    Measured: From first dose to death from any cause, assessed up to 3 years

  5. Duration of response (DOR)

    DOR will be estimated using Kaplan-Meier method. Approximate 95% CIs for median DOR will be computed using the Brookmeyer and Crowley method.

    Measured: From the first tumor assessment supports the response to the time of confirmed disease progression or death due to any cause, whichever occurs first, assessed up to 3 years

  6. Time to next anti-lymphoma treatment

    Time to next anti-lymphoma treatment is defined as the time from the end of induction visit up to and including the date of initiation of next treatment for any reason. This includes any chemotherapy, antibody therapy, oral therapy, and radiation therapy. Time to next anti-lymphoma treatment will be estimated using Kaplan-Meier methodology. Approximate 95% CIs for median time to next anti-lymphoma treatment will be computed using the Brookmeyer and Crowley method

    Measured: From the end of induction visit up to and including the date of initiation of next treatment for any reason, assessed up to 3 years

  7. Quality of life (QOL) assessments

    QOL measures from the Functional Assessment of Cancer Therapy General questionnaire obtained during treatment will be compared to the baseline values obtained at the screening visit using paired t-tests, McNemar's tests, or their nonparametric equivalents, where appropriate.

    Measured: Up to 3 years

  8. Patient-reported adverse events.

    Categorical Patient Reported Outcomes (PRO)-CTCAE variables will be summarized using frequencies and percentages, and numeric PRO-CTCAE variables will be summarized using mean, median, standard deviation, interquartile range (IQR), and range.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start3 Sep 2021
  3. Primary completion23 Sep 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883437
Sponsor's protocol ID
STUDY00002247
Other IDs
NCI-2021-00894, STUDY00002247, WINSHIP5186-20, P30CA138292
Status last verified
Feb 2026
First submitted
7 May 2021
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acalabrutinib, Obinutuzumab and Quality-of-Life Assessment in people with Grade 1 Follicular Lymphoma and Grade 2 Follicular Lymphoma, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathon Cohen, MD, MS (404-778-2419, jonathon.cohen@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate (time frame: Up to start of cycle 6 (each cycle = 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04883437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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