Active, not recruitingNCT02180711Updated Sep 28, 2026Results posted

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

A Phase 1/2 interventional study of acalabrutinib and rituximab (IV) in Non Hodgkin Lymphoma, sponsored by Acerta Pharma BV. Active, not recruiting at 29 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Acerta Pharma BV · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 113
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

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 studied

Non Hodgkin Lymphoma

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Keywords

Bruton tyrosine kinase inhibitor
Btk
Follicular Lymphoma
FL
acalabrutinib
ACP-196
MZL
Marginal Zone Lymphoma

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 113 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Acerta Pharma BV is the lead sponsor of 40 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 3 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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
- 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.

Exclusion criteria

Exclusion Criteria:

•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

Study design

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

Study arms

Experimental
Part 1: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
Drug: acalabrutinib
Experimental
Part 1: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
Drug: acalabrutinib · Drug: rituximab (IV)
Experimental
Part 2: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
Drug: acalabrutinib
Experimental
Part 2: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
Drug: acalabrutinib · Drug: rituximab (IV)
Experimental
Part 3: acalabrutinib Regimen 1
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
Drug: acalabrutinib · Drug: rituximab (IV) · Drug: Lenalidomide

Interventions

Drugacalabrutinib
Also known as: ACP-196
Drugrituximab (IV)
DrugLenalidomide

What researchers measure

Primary outcomes

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).
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).
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).
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).
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).
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).

Results

Posted Oct 15, 2025

Participant flow

Participant flow — Overall Study
Milestone	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
Started	12	13	2	13	43	1	8	21
Completed	0	0	0	0	0	0	0	0
Not completed	12	13	2	13	43	1	8	21
Withdrew: Death	0	1	0	0	7	0	1	3
Withdrew: Lost to follow-up	0	1	0	0	1	1	0	3
Withdrew: Withdrawal by subject	2	1	0	4	3	0	3	2
Withdrew: - disease progression	0	1	0	0	0	0	0	0
Withdrew: - subject started alternative cancer therapy	7	6	2	2	0	0	0	0
Withdrew: - study terminated by sponsor	2	3	0	5	32	0	4	13
Withdrew: - enrolled into follow-up study	0	0	0	1	0	0	0	0
Withdrew: - other	1	0	0	1	0	0	0	0

Outcome measures

PrimaryPart 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).

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).
Reported as:: Number · Number of participants

Part 1: Incidence of Treatment-emergent Adverse Events.
Number of participants	Part 1: Acalabrutinib 100 mg BID	Part 1: Acalabrutinib 100 mg BID + Rituximab	Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD	Part 1: Acalabrutinib 100 mg Rituximab
Part 1: Incidence of Treatment-emergent Adverse Events.	12	13	2	13

PrimaryPart 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).

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).
Reported as:: Number · Percentage of participants

Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
Percentage of participants	Part 2: Acalabrutinib	Part 2: Acalabrutinib + Rituximab
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).	60.5 (44.4 to 75.0)	0 (0 to 97.5)

PrimaryPart 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).

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).
Reported as:: Number · Number of participants

Part 3: Incidence of Treatment-emergent Adverse Events.
Number of participants	Part 3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	Part3: Acalabrutinib + Rituximab + Lenalidomide+20mg
Part 3: Incidence of Treatment-emergent Adverse Events.	8	21

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
P1: RR Acalabrutinib 100 mg BID	0/12 (0%)	2/12 (16.7%)	12/12 (100%)
P1: RR Acalabrutinib 100 mg BID + Rituximab	1/13 (7.7%)	5/13 (38.5%)	13/13 (100%)
P1: RR Acalabrutinib 200 mg QD	0/2 (0%)	0/2 (0%)	2/2 (100%)
P1: TN Acalabrutinib 100 mg BID + Rituximab	0/13 (0%)	3/13 (23.1%)	13/13 (100%)
P2: Acalabrutinib	7/43 (16.3%)	9/43 (20.9%)	41/43 (95.3%)
P2: Acalabrutinib + Rituximab	0/1 (0%)	1/1 (100%)	1/1 (100%)
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	1/8 (12.5%)	4/8 (50%)	8/8 (100%)
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	3/21 (14.3%)	11/21 (52.4%)	21/21 (100%)

Most frequent serious events

Showing 10 of 46

Most frequent serious events
Event	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
SepsisInfections and infestations	0/12	0/13	0/2	0/13	0/43	1/1	0/8	2/21
Covid-19 pneumoniaInfections and infestations	0/12	0/13	0/2	0/13	0/43	0/1	0/8	4/21
PneumoniaInfections and infestations	1/12	0/13	0/2	0/13	1/43	0/1	0/8	3/21
Pneumonia influenzalInfections and infestations	0/12	0/13	0/2	0/13	0/43	0/1	1/8	0/21
DehydrationMetabolism and nutrition disorders	0/12	0/13	0/2	0/13	0/43	0/1	1/8	0/21
AphasiaNervous system disorders	0/12	0/13	0/2	0/13	0/43	0/1	1/8	0/21
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	0/12	0/13	0/2	0/13	1/43	0/1	1/8	0/21
Duodenal ulcerGastrointestinal disorders	0/12	0/13	0/2	0/13	0/43	0/1	1/8	0/21
Covid-19Infections and infestations	0/12	0/13	0/2	0/13	1/43	0/1	1/8	2/21
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/12	0/13	0/2	0/13	0/43	0/1	0/8	0/21

Most frequent other events

Showing 10 of 246

Most frequent other events
Event	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
Blood creatinine increasedInvestigations	1/12	1/13	0/2	0/13	8/43	1/1	1/8	2/21
Haemoglobin decreasedInvestigations	0/12	0/13	0/2	0/13	0/43	1/1	0/8	0/21
White blood cell count decreasedInvestigations	0/12	0/13	0/2	1/13	0/43	1/1	0/8	3/21
Decreased appetiteMetabolism and nutrition disorders	2/12	3/13	0/2	1/13	4/43	1/1	1/8	4/21
HeadacheNervous system disorders	7/12	5/13	0/2	6/13	15/43	1/1	3/8	8/21
DyspnoeaRespiratory, thoracic and mediastinal disorders	3/12	2/13	1/2	2/13	5/43	1/1	1/8	6/21
AlopeciaSkin and subcutaneous tissue disorders	0/12	1/13	0/2	1/13	4/43	1/1	0/8	1/21
Ingrowing nailSkin and subcutaneous tissue disorders	0/12	0/13	0/2	0/13	0/43	1/1	0/8	0/21
PruritusSkin and subcutaneous tissue disorders	1/12	2/13	0/2	2/13	3/43	1/1	3/8	6/21
UrticariaSkin and subcutaneous tissue disorders	1/12	0/13	0/2	0/13	0/43	1/1	0/8	0/21

Baseline characteristics

The All-treated Population, defined as all subjects who received at least 1 dose of study treatment.

Age, Continuous
Age, Continuous(Years)	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	Total
Mean	63.3 ± 16.0	66.7 ± 10.6	59.0 ± 21.2	59.6 ± 12.2	66.0 ± 10.0	43.0 ± NA	62.5 ± 9.7	63.0 ± 9.7	64.0 ± 11.2

Sex: Female, Male
Sex: Female, Male(Participants)	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	Total
Female	6	8	1	8	17	1	1	6	48
Male	6	5	1	5	26	0	7	15	65

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	Total
Hispanic or Latino	0	2	0	1	1	0	3	3	10
Not Hispanic or Latino	12	11	2	12	41	1	5	17	101
Not Reported	0	0	0	0	1	0	0	1	2

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	Total
Asian	0	0	0	1	0	0	0	1	2
Black or African American	1	0	0	0	4	0	0	2	7
Not Reported	0	0	0	0	1	0	1	1	3
White	11	13	2	12	38	1	7	17	101

Region of Enrollment
Region of Enrollment(Participants)	P1: RR Acalabrutinib 100 mg BID	P1: RR Acalabrutinib 100 mg BID + Rituximab	P1: RR Acalabrutinib 200 mg QD	P1: TN Acalabrutinib 100 mg BID + Rituximab	P2: Acalabrutinib	P2: Acalabrutinib + Rituximab	P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg	P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg	Total
Canada	0	0	0	0	4	0	0	5	9
Italy	0	0	0	0	3	0	0	0	3
United States	12	13	2	13	36	1	8	16	101

Study locations

29 sites

Research Site
Tucson, Arizona 85719, United States
Research Site
Downey, California 90241, United States
Research Site
Duarte, California 91010, United States
Research Site
Fountain Valley, California 92708, United States
Research Site
Santa Monica, California 90404, United States
Research Site
Coral Gables FL, Florida 33146, United States
Research Site
Chicago, Illinois 60611, United States
Research Site
Chicago, Illinois 60612, United States
Research Site
Chicago, Illinois 60637, United States
Research Site
Louisville, Kentucky 40207, United States
Research Site
New Orleans, Louisiana 70112, United States
Research Site
Ann Arbor, Michigan 48109, United States
Research Site
Morristown, New Jersey 07960, United States
Research Site
Lake Success, New York 11042, United States
Research Site
New York, New York 10021, United States
Research Site
Columbus, Ohio 43210, United States
Research Site
Greenville, South Carolina 29615, United States
Research Site
Dallas, Texas 75235, United States
Research Site
Houston, Texas 77030, United States
Research Site
San Antonio, Texas 78217, United States
Research Site
Temple, Texas 76508, United States
Research Site
Salt Lake City, Utah 84112, United States
Research Site
Spokane, Washington 99208, United States
Research Site
Edmonton, Alberta t6G1Z2, Canada
Research Site
London, Ontario N6A 5W9, Canada
Research Site
Toronto, Ontario M5G 2M9, Canada
Research Site
Bologna, 40138, Italy
Research Site
Milan, 20132, Italy
Research Site
Palermo, 90146, Italy

References and documents

Study documents

Study protocol · Oct 12, 2023
Statistical analysis plan · Mar 31, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: registry notes, identifiers and verification date

1 update, last Sep 28, 2026

Show all 1 update

Sep 28, 2026
Minor edits only
+ 3 other changes: registry notes, identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02180711
Lead sponsor: Acerta Pharma BV
Collaborators: AstraZeneca
Responsible party: Sponsor
First posted: Jul 3, 2014
Start date: Dec 29, 2014
Primary completion: Aug 25, 2023
Completion: Dec 11, 2028 (estimated)
Results posted: Oct 15, 2025
Last update: Sep 28, 2026

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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