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An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma
EU CTIS ID: 2023-509350-63-00
What this study is testing
PART 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women ≥18 years of age.
- Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
- Previous therapy: a. Cohort 1: Previously received 1 or more lines of systemic therapy including at least 1 CD20-directed regimen (either as monotherapy or as chemoimmunotherapy for MZL) with documented failure to achieve at least PR, or documented disease progression after the most recent treatment regimen. b. Cohort 2: Previously received 1 or more lines of therapy including at least 1 prior systemic therapy for MZL or radiation therapy with documented failure to achieve at least PR, or document disease progression after the most recent treatment regimen.
- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures ≥2.0 cm in the longest dimension and ≥1.0 cm in the longest perpendicular dimension as assessed by CT scan).
- ECOG performance status of ≤2.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent
You likely can't join if
- Prior malignancy (other than indolent B-cell NHL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥2 years.
- Known history of infection with HIV.
- Serologic status reflecting active hepatitis B or C infection.
- History of allogeneic stem cell (or organ) transplantation.
- History of stroke or intracranial hemorrhage within 6 months before the first dose of acalabrutinib.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonist (e.g., phenprocoumon) within 7 days of first dose of study drug.
See the full eligibility criteria
Who can join
- Men and women ≥18 years of age.
- Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
- Previous therapy: a. Cohort 1: Previously received 1 or more lines of systemic therapy including at least 1 CD20-directed regimen (either as monotherapy or as chemoimmunotherapy for MZL) with documented failure to achieve at least PR, or documented disease progression after the most recent treatment regimen. b. Cohort 2: Previously received 1 or more lines of therapy including at least 1 prior systemic therapy for MZL or radiation therapy with documented failure to achieve at least PR, or document disease progression after the most recent treatment regimen.
- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures ≥2.0 cm in the longest dimension and ≥1.0 cm in the longest perpendicular dimension as assessed by CT scan).
- ECOG performance status of ≤2.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent
What rules you out
- Prior malignancy (other than indolent B-cell NHL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥2 years.
- Known history of infection with HIV.
- Serologic status reflecting active hepatitis B or C infection.
- History of allogeneic stem cell (or organ) transplantation.
- History of stroke or intracranial hemorrhage within 6 months before the first dose of acalabrutinib.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonist (e.g., phenprocoumon) within 7 days of first dose of study drug.
- ANC <1.0 × 109/L or platelet count <100 × 109/L. For subjects with documented disease involvement in the bone marrow, ANC <0.50 × 109/L or platelet count <30 × 109/L.
- Creatinine >1.5 × institutional ULN; total bilirubin >1.5 × ULN; and AST or ALT >2.5 × ULN.
- Breastfeeding or pregnant.
- Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
- History of or ongoing progressive multifocal leukoencephalopathy (PML).
- Known medically apparent CNS lymphoma or leptomeningeal disease.
- Known evidence of transformation to another aggressive lymphoma.
- 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.
- Known history of a bleeding diathesis (e.g., hemophilia, von Willebrand disease).
- 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 corrected QT interval using Fridericia formula (QTcF) >480 msec.
- Prior exposure to a BCR inhibitor (e.g., BTK, or SYK inhibitors).
- Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment or other conditions within 1 week before the first dose of study drug.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.