Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma (NCT04462328) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma
United States25 participantsStarted 2021-04-29
Plain-language summary
BTK inhibition and checkpoint blockade are promising classes of therapy for central nervous system (CNS) lymphoma and have demonstrated efficacy with acceptable toxicity. A multidrug approach may carry a higher chance of durable efficacy in this aggressive disease that carries significant morbidity and mortality. Given the poor outcomes and limited options for patients who are not candidates for high-dose methotrexate, the investigators seek to evaluate the combination in this patient population.
08/30/2022: The study was originally designed for those with primary and secondary central nervous system (CNS) lymphoma. However, the first three patients who were enrolled all had secondary CNS lymphoma and most had germinal center phenotype disease with double hit phenotypes. In these three patients, two dose limiting toxicities were seen including 1 patient with grade 4 neutropenia at the time of disease progression and one with pneumonia in the setting of disease progression and worsening of existing heart disease. The third patient came off for clinical progression within cycle 1. Given the lack of response in patients with secondary CNS lymphomas, who do not exhibit the same biology as primary CNS lymphoma patients, Amendment 3 updates the study to only include patients with primary CNS lymphomas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically documented primary CNS lymphoma with either:
* Relapsed or refractory disease with at least 1 prior therapy OR
* Ineligible for high dose methotrexate based therapy as determined by the treating physician, including previously untreated patients. Examples of medical conditions that for which a patient could be considered ineligible for high dose methotrexate include renal impairment, liver disease, heart failure or having ascites or effusions.
Note: Patients with leptomeningeal disease only must have been previously treated with intrathecal therapy Note: Patients with secondary CNS lymphoma are excluded even if the disease is isolated to the CNS.
* Presence of evaluable disease. This includes radiographic evidence of parenchymal disease or leptomeningeal enhancement or thickening, or disease detected in the CSF.
Note: Patients with vitreous involvement alone are not eligible.
* ECOG performance status of 0, 1, or 2. Patients with ECOG performance status of 3 are permitted if their performance status limitations are due to lymphoma in the opinion of the treating physician.
* Adequate bone marrow and organ function shown by:
* Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
* Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 7 days prior to initiation of protocol treatment
* Prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR) \< 2 times the upper limit of normal…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerability as defined as tolerable dose
Timeframe: Completion of first 12 weeks of treatment within phase I portion of study (estimated to be 14 months)
2
Safety as defined by frequency of toxicities assessed by CTCAE v 5.0
Timeframe: From start of treatment through 90 days after treatment (estimated to be 9 months)