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
Qualifiers
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
Treatments tested in this trial
- DA-EPOCH
- Rituximab
- CHOP
- Acalabrutinib