Trial Title:
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
NCT ID:
NCT02180711
Condition:
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Rituximab
Lenalidomide
Acalabrutinib
Conditions: Keywords:
Bruton tyrosine kinase inhibitor
Btk
Follicular Lymphoma
FL
acalabrutinib
ACP-196
MZL
Marginal Zone Lymphoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
acalabrutinib
Arm group label:
Part 1: acalabrutinib Regimen 1
Arm group label:
Part 1: acalabrutinib Regimen 2
Arm group label:
Part 2: acalabrutinib Regimen 1
Arm group label:
Part 2: acalabrutinib Regimen 2
Arm group label:
Part 3: acalabrutinib Regimen 1
Other name:
ACP-196
Intervention type:
Drug
Intervention name:
rituximab (IV)
Arm group label:
Part 1: acalabrutinib Regimen 2
Arm group label:
Part 2: acalabrutinib Regimen 2
Arm group label:
Part 3: acalabrutinib Regimen 1
Intervention type:
Drug
Intervention name:
Lenalidomide
Arm group label:
Part 3: acalabrutinib Regimen 1
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
Detailed description:
An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in
Subjects with B-cell Non-Hodgkin Lymphoma
Criteria for eligibility:
Criteria:
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
1. Subjects with splenic MZL must have an additional measurable lesion, nodal or
extranodal, as described in inclusion criterion #4;
2. 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:
- •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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Tucson
Zip:
85719
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Downey
Zip:
90241
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Coral Gables FL
Zip:
33146
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Chicago
Zip:
60637
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Louisville
Zip:
40207
Country:
United States
Facility:
Name:
Research Site
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Morristown
Zip:
07960
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Hawthorne
Zip:
10532
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10021
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Greenville
Zip:
29615
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75235
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Research Site
Address:
City:
San Antonio
Zip:
78217
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Temple
Zip:
76508
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Spokane
Zip:
99208
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Waukesha
Zip:
53188
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Edmonton
Zip:
t6G1Z2
Country:
Canada
Facility:
Name:
Research Site
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Facility:
Name:
Research Site
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Research Site
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Start date:
December 29, 2014
Completion date:
December 29, 2028
Lead sponsor:
Agency:
Acerta Pharma BV
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Acerta Pharma BV
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02180711
