Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Phase II Trial of Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

NCT04094142•Seoul National University Hospital

Summary

NCCN guidelines for B cell lymphoma suggest that patients with relapsed/refractory aggressive NHL who are candidate for high-dose therapy should receive combination of cytotoxic chemotherapies as 2nd line treatment. However, proportion of patients who are adequately salvaged by second line chemotherapy and high-dose chemotherapy with stem cell rescue is unsatisfactory. Moreover, many fragile patients are unfit for salvage cytotoxic chemotherapy and/or high-dose chemotherapy. Hence, most of patients with relapsed/refractory aggressive B-cell NHL is ultimately candidate for less-cytotoxic drugs with targeted approach. This trial is phase II trial of acalabrutinib in combination with rituximab and lenalidomide for these patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women ≥ 18 years of age.
•2. Diagnosed with aggressive B cell non-Hodgkin lymphoma
•* Diffuse large B cell lymphoma (Both GCB and non-GCB)
•: GCB type should not be more than 40% (N=26) of whole study population (Would limit number of GCB patients by maximum of 26)
•* Primary mediastinal B cell lymphoma
•* Transformed follicular lymphoma
•* Small lymphocytic lymphoma with Richter transformation
•3. Failed previous treatments and last dose administered must be more than 2-week ahead from enrollment
•* Should have received anti-CD20 based chemotherapy previously
•* Failed at least two lines of therapy if patient is candidate for autologous stem cell transplantation
+5 more criteria

Exclusion Criteria

•1. Diagnosed with mantle cell lymphoma
•2. Previously treated with more than four lines of chemotherapy (Consolidative autologous stem cell transplantation is deemed as the same line therapy)
•3. Previously treated with allogeneic hematopoietic stem cell transplantation within 6 months
•4. GVHD requiring treatment
•5. Patient who cannot take drug per oral
•6. Known resistance to both BTK inhibitor and lenalidomide (Progression free survival to both BTK inhibitor and lenalidomide \< 6 months)
•7. Known resistant mutation to BTK inhibitor (BTKC481S and PLGCR665W)
•8. Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years or which will not limit survival to \< 5 years.
•9. Clinically 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. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
•10. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
+18 more criteria

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

July 9, 2019

Primary Completion Date

May 15, 2022

Completion Date

May 15, 2022

Last Updated

April 18, 2023

Enrollment

ACTUAL participants

Conditions

Non-hodgkin Lymphoma,B Cell

Interventions

Acalabrutinib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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