Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma (NCT04639843) | Clinical Trial Compass
WithdrawnPhase 1
Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
Stopped: Safety issues with PI3 kinase inhibitors
United States0Started 2022-11-03
Plain-language 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....
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with newly diagnosed (Cohort 2) or relapsed/refractory (Cohorts 1 and 3) T-cell lymphoma (TCL) defined as follows (per 2016 WHO classification):
. PTCL from initial diagnosis or recurrence must be histologically or cytologically proven and diagnosis be confirmed by the Laboratory of Pathology, NCI.
. For patients without circulating lymphoma cells detectable by flow cytometry, a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh) must be available at enrollment for performance of correlative studies. NOTE: Patients without circulating malignant cells must be willing to have a tumor biopsy if prior tissue or adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).
. Disease must be measurable with at least one measurable lesion by RECIL 2017 criteria or with an abnormal clonal T-cell population detectable by peripheral blood flow cytometry.
. Age \>=18 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. LVEF within institutional parameters as determined by echocardiography.
. DLCO/VA Adjusted and FEV1 \>=50% of reference.
Exclusion criteria
. Patients who are receiving any other investigational agents.
. Patients in need of immediate cytoreduction.
. Chemotherapy or monoclonal antibody therapy within 4 weeks prior to start of treatment (6 weeks for nitrosoureas or mitomycin C); small molecule or radiation therapy within 2 weeks.
. Prior radiation therapy to chest with fields involving the heart.
. Major surgery within 4 weeks prior to start of treatment
. History of tuberculosis treatment within the 2 years prior to start of treatment
. Administration of a live or live attenuated vaccine within 6 weeks prior to start of treatment, or of mRNA and adenovirus-based vaccines within 2 weeks prior to start of treatment