Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Summary

Background: T-cell lymphomas (TCLs) are rare cancers. Many types of TCLs do not develop in the lymph nodes but in places like the skin, spleen, and bone marrow. Researchers want to see if a mix of 4 drugs can help people with TCL. Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), duvelisib, and doxorubicin can be used safely in people with TCL. Eligibility: Adults 18 and older with TCL that is newly diagnosed or that returned after or did not respond to standard treatments. Design: Participants will be screened on a separate protocol. They may have a tumor biopsy. Participants will have medical histories, medicine reviews, and physical exams. Their ability to do daily activities will be assessed. They will have blood and urine tests. Participants will take duvelisib and CC-486 (5-azacitidine) by mouth. They will get romidepsin and doxorubicin by intravenous infusion. They will take the drugs for up to eight 21-day cycles. They will keep a medicine diary. Participants will have a bone marrow aspiration and/or biopsy. Bone marrow will be taken through a needle inserted in the hip. Participants will have tumor imaging scans. Some may have a brain MRI and lumbar puncture. Some may have skin assessments. Participants will give blood, saliva, and tumor samples for research. Participants will have a safety visit 30 days after treatment ends. Then they will have follow-up visits every 60 days for 6 months, then every 90 days for 2 years, and then every 6 months for 2 years. Then they will have yearly visits until their disease gets worse or they start a new treatment....

Timeline

Start

2022-11-03

Primary completion

2022-11-03

Completion

2022-11-03

Drugs

Indications