Non Hodgkin LymphomaPhase 1/2NCT02180711

Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

A Phase 1/2 study testing acalabrutinib, rituximab (IV) and Lenalidomide in people with Non Hodgkin Lymphoma, run by Acerta Pharma BV at 29 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Hodgkin Lymphoma
What is being tested?: acalabrutinib, rituximab (IV) and Lenalidomide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 29 sitesin 3 countries
Study dates: 29 Dec 2014to 11 Dec 2028
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment.
Part 2: For subject with relapsed or refractory MZL:
Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;
Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative

Show all 9Show fewer

Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which requires treatment per National Cancer Institute or ESMO clinical practice guidelines.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Who cannot join

•A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
Significant cardiovascular disease such as uncontrolled or symptomatic 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, or Qtc >480 msec
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Breast feeding or pregnant

Trial locations and contacts

29 sites in 3 countries.

Country

City, postcode or hospital

29 sites in 3 countries

United States23 sites

Research Site
Ann Arbor, Michigan, 48109
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois, 60637
Research Site
Columbus, Ohio, 43210
Research Site
Coral Gables FL, Florida, 33146
Research Site
Dallas, Texas, 75235
Research Site
Downey, California, 90241
Research Site
Duarte, California, 91010
Research Site
Fountain Valley, California, 92708
Research Site
Greenville, South Carolina, 29615
Research Site
Houston, Texas, 77030
Research Site
Lake Success, New York, 11042
Research Site
Louisville, Kentucky, 40207
Research Site
Morristown, New Jersey, 07960
Research Site
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10021
Research Site
Salt Lake City, Utah, 84112
Research Site
San Antonio, Texas, 78217
Research Site
Santa Monica, California, 90404
Research Site
Spokane, Washington, 99208
Research Site
Temple, Texas, 76508
Research Site
Tucson, Arizona, 85719

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Canada3 sites

Research Site
Edmonton, Alberta, t6G1Z2
Research Site
London, Ontario, N6A 5W9
Research Site
Toronto, Ontario, M5G 2M9

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Italy3 sites

Research Site
Bologna, 40138
Research Site
Milan, 20132
Research Site
Palermo, 90146

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About this study

Official title: An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.

Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.

Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Read the detailed description

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Conditions: Non Hodgkin Lymphoma
Being tested: acalabrutinib, rituximab (IV), Lenalidomide
Keywords: Bruton tyrosine kinase inhibitor, Btk, Follicular Lymphoma, FL, acalabrutinib, ACP-196, MZL, Marginal Zone Lymphoma
Medical subject headings: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

acalabrutinibDrug
Also called ACP-196
rituximab (IV)Drug
LenalidomideDrug

Study groups in NCT02180711
Study group	Role	What they receive
Part 1: acalabrutinib Regimen 1	Experimental	acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects Receives: Drug: acalabrutinib
Part 1: acalabrutinib Regimen 2	Experimental	acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects Receives: Drug: acalabrutinib; Drug: rituximab (IV)
Part 2: acalabrutinib Regimen 1	Experimental	acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects Receives: Drug: acalabrutinib
Part 2: acalabrutinib Regimen 2	Experimental	acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects Receives: Drug: acalabrutinib; Drug: rituximab (IV)
Part 3: acalabrutinib Regimen 1	Experimental	acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects Receives: Drug: acalabrutinib; Drug: rituximab (IV); Drug: Lenalidomide

What is being measured

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

Part 1: Incidence of Treatment-emergent Adverse Events.
Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
Measured: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Measured: Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
Part 3: Incidence of Treatment-emergent Adverse Events.
Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL).
Measured: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).

Timeline

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

29 Dec 201411 Dec 2028

First posted3 Jul 2014 (estimated)
Study start29 Dec 2014
Primary completion25 Aug 2023
Study completion11 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by Acerta Pharma BVThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180711
Sponsor's protocol ID: ACE-LY-003
Other IDs: 2023-509350-63-00, 2019-000111-84, 2019, 2023
Status last verified: Sep 2026
First submitted: 30 Jun 2014
Last updated: 28 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT02180711
Acronym / sponsor ID: ACE-LY-003
Conditions: Non Hodgkin Lymphoma
Keywords: Bruton tyrosine kinase inhibitor, Btk, Follicular Lymphoma, FL, acalabrutinib, ACP-196, MZL, Marginal Zone Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 113 participants (actual)
Lead sponsor: Acerta Pharma BVIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: 29 Dec 2014 (actual)
Primary completion: 25 Aug 2023 (actual)
Study completion: 11 Dec 2028 (estimated)
First posted: 3 Jul 2014 (estimated)
Results: Posted 15 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.

Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.

Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Detailed description

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Part 1: acalabrutinib Regimen 1	Experimental	Drug: acalabrutinibacalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
Part 1: acalabrutinib Regimen 2	Experimental	Drug: acalabrutinib, Drug: rituximab (IV)acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
Part 2: acalabrutinib Regimen 1	Experimental	Drug: acalabrutinibacalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
Part 2: acalabrutinib Regimen 2	Experimental	Drug: acalabrutinib, Drug: rituximab (IV)acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
Part 3: acalabrutinib Regimen 1	Experimental	Drug: acalabrutinib, Drug: rituximab (IV), Drug: Lenalidomideacalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Men and women ≥ 18 years of age.
Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment.
Part 2: For subject with relapsed or refractory MZL:
Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;

Key exclusion criteria (4 listed)

•A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
Significant cardiovascular disease such as uncontrolled or symptomatic 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, or Qtc >480 msec
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Breast feeding or pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acalabrutinibAlso: ACP-196	Drug	Part 1: acalabrutinib Regimen 1, Part 1: acalabrutinib Regimen 2, Part 2: acalabrutinib Regimen 1, Part 2: acalabrutinib Regimen 2, Part 3: acalabrutinib Regimen 1
rituximab (IV)	Drug	Part 1: acalabrutinib Regimen 2, Part 2: acalabrutinib Regimen 2, Part 3: acalabrutinib Regimen 1
Lenalidomide	Drug	Part 3: acalabrutinib Regimen 1

Primary outcome

Part 1: Incidence of Treatment-emergent Adverse Events.
Time frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
Time frame: Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Part 3: Incidence of Treatment-emergent Adverse Events.
Time frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).
Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL).

Results and safety

Results posted to the registry on 15 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P1: RR Acalabrutinib 100 mg BID	12	0
P1: RR Acalabrutinib 100 mg BID + Rituximab	13	0
P1: RR Acalabrutinib 200 mg QD	2	0
P1: TN Acalabrutinib 100 mg BID + Rituximab	13	0
P2: Acalabrutinib	43	0
P2: Acalabrutinib + Rituximab	1	0
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	8	0
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	21	0

Primary outcome: Part 1: Incidence of Treatment-emergent Adverse Events.

Time frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).. Number. Unit: Number of participants

Measure	Part 1: Acalabrutinib 100 mg BID n = 12	Part 1: Acalabrutinib 100 mg BID + Rituximab n = 13	Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD n = 2	Part 1: Acalabrutinib 100 mg Rituximab n = 13
Value	12	13	2	13

Primary outcome: Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Time frame: Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Part 2: Acalabrutinib n = 43	Part 2: Acalabrutinib + Rituximab n = 1
Value	60.5 (44.4 to 75.0)	0 (0 to 97.5)

Primary outcome: Part 3: Incidence of Treatment-emergent Adverse Events.

Time frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).. Number. Unit: Number of participants

Measure	Part 3: Acalabrutinib + Rituximab + Lenalidomide 15 mg n = 8	Part3: Acalabrutinib + Rituximab + Lenalidomide+20mg n = 21
Value	8	21

Adverse events

Time frame: Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P1: RR Acalabrutinib 100 mg BID	2 of 12 (16.7%)	12 of 12 (100%)	0 of 12
P1: RR Acalabrutinib 100 mg BID + Rituximab	5 of 13 (38.5%)	13 of 13 (100%)	1 of 13
P1: RR Acalabrutinib 200 mg QD	0 of 2 (0%)	2 of 2 (100%)	0 of 2
P1: TN Acalabrutinib 100 mg BID + Rituximab	3 of 13 (23.1%)	13 of 13 (100%)	0 of 13
P2: Acalabrutinib	9 of 43 (20.9%)	41 of 43 (95.3%)	7 of 43
P2: Acalabrutinib + Rituximab	1 of 1 (100%)	1 of 1 (100%)	0 of 1
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	4 of 8 (50%)	8 of 8 (100%)	1 of 8
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	11 of 21 (52.4%)	21 of 21 (100%)	3 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Redacted CSPLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.
Redacted CSR synopsisLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing acalabrutinib, rituximab (IV) and Lenalidomide in people with Non Hodgkin Lymphoma, run by Acerta Pharma BV at 29 sites in 3 countries.

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 9 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada, Italy. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of Treatment-emergent Adverse Events. (time frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).). The study lists 3 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 NCT02180711.

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 28 Sep 2026.