About this trial
Background:
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.
Objective:
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.
Eligibility:
People ages 18 and older with an aggressive B-cell lymphomas that have not been treated
Design:
Participants will be screened with:
Blood and urine tests
Physical exam
Medical history
Tumor biopsy
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.
Imaging scans
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
DLBCL, NOS, Activated B-cell type (ABC)
DLBCL, NOS, Germinal center B-cell type (GCB)
T-cell/histiocyte-rich large B-cell lymphoma
Primary cutaneous DLBCL, leg-type
Disqualifiers
Primary DLBCL of the central nervous system (PCNSL)
Primary mediastinal B-cell lymphoma (PMBL)
Plasmablastic lymphoma
Intravascular large B-cell lymphoma
Trial design
Single group
Treatments tested in this trial
DA-EPOCH
DrugVincristine 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
Biological/VaccineRituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for 6 cycles.
CHOP
DrugCyclophosphamide 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
DrugAcalabrutinib 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 the first 10 days for 6 cycles.
Treatment groups
Trial outcomes
Primary outcomes
Response rate
Number of patients who achieve a CR, PR or SD
Secondary outcomes
Safety and tolerability
Incidence of adverse events (i.e., grade and frequency)
Progression-free survival
The response rate will be determined and reported along with a 95% confidence interval.
Overall survival
The response rate will be determined and reported along with a 95% confidence interval.
Event-free survival
The response rate will be determined and reported along with a 95% confidence interval.
Sponsors and contacts
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