Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04002947|
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : June 22, 2020
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.
To see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.
People ages 18 and older with an aggressive B-cell lymphomas that have not been treated
Participants will be screened with:
Blood and urine tests
Bone marrow biopsy: A needle will remove marrow from the participant s hipbone.
Lumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.
Participants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.
Participants may have 4 doses of another drug injected into their spinal fluid.
Participants will have repeats of the screening tests throughout the study.
Participants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma Non Hodgkin's Lymphoma DLBCL NHL||Drug: DA-EPOCH Biological: Rituximab Drug: CHOP Drug: Acalabrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma|
|Actual Study Start Date :||August 5, 2019|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||March 31, 2028|
Acalabrutinib 100 mg orally twice a day for 14 days; Following window: patients with > or = to 25% tumor reduction, treat with DA-EPOCH-R or RCHOP + acalabrutinib 100mg orally twice a day for the first 10 days, for 6 cycles; whereas, patients with <25% tumor reduction, treat with DA-EPOCH-R or RCHOP alone for 6 cycles
Vincristine 1.4 mg /m2 (2 mg cap) IV on Day 1, Doxorubicin 10 mg/m2/day CIVI on Days 1-4, Etoposide 50 mg/m2 /day CIVI on Days 1-4, Cyclophosphamide 750 mg/m2 IV on Day 5. Prednisone 60 mg/m2 PO BID is administered daily on Days 1-5 of each cycle. Each cycle is 21 days and drugs will be given for 6 cycles.
Rituximab 375 mg /m2 IV on Day 1 of each 21-day cycle for 6 cycles.
Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg /m2 IV, Vincristine 1.4 mg/m2 (2 mg cap) IV are administered on Day 1 of each 21-day cycle for 6 cycles. Prednisone 40 mg/m2 PO is administered daily on Days 1-5 of each cycle.
Acalabrutinib is administered orally at 100 mg twice a day for 14 days during the window period. During combination therapy, acalabrutinib is administered 100 mg twice daily for thefirst 10 days for 6 cycles.
- Response rate [ Time Frame: every 2 cycles ]Number of patients who achieve a CR, PR or SD
- Progression-free survival [ Time Frame: every 3-6 months for 5 years then yearly ]The response rate will be determined and reported along with a 95% confidence interval.
- Complete response rate [ Time Frame: 6 cycles ]The response rate will be determined and reported along with a 95% confidence interval.
- Event-free survival [ Time Frame: every 3-6 months for 5 years then yearly ]The response rate will be determined and reported along with a 95% confidence interval.
- Safety and tolerability [ Time Frame: initiation of study drug until 30 days after last dose ]Incidence of adverse events (i. e., grade and frequency)
- Overall survival [ Time Frame: every 3-6 months for 5 years then yearly ]The response rate will be determined and reported along with a 95% confidence interval.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002947
|Contact: NCI Medical Oncology Referral Office||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|