Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell L… (NCT04233697) | Clinical Trial Compass
WithdrawnPhase 1
Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma
Stopped: Investigator left institution
0Started 2020-02
Plain-language summary
This is an open label, Phase IB dose-escalation study of the PI3K inhibitor copanlisib in combination with romidepsin in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL).
The primary objective of the phase I study is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dose limiting toxicities (DLTs) of the combination of copanlisib and romidepsin in patients with R/R, NHL or HL.
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:
* Be willing and able to provide written informed consent for the trial.
* Be ≥18 years of age on day of signing informed consent.
* Have measurable disease based on the Lugano Criteria.
* Phase I: patient must have histologically confirmed R/R NHL or HL (defined by World Health Organization (WHO) criteria).
* Expansion phase: patients must have histologically confirmed R/R mature T-cell lymphoma (defined by WHO criteria).
* Patient must have received at least two prior lines of therapy prior to enrollment in this study.
* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Left Ventricular Ejection Fraction (LVEF) \> 50%.
* Demonstrate adequate organ function. All screening labs should be performed within 10 days of treatment initiation. The following treatments are prohibited: (a) Chemotherapy, monoclonal antibody within 4 weeks; (b) radiotherapy within 2 weeks prior to entering the study; (c) systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs; (d) other concurrent investigational agents within 4 weeks prior to entering the study; (e) use of copanlisib or romidepsin within the past 3 months.
* Patients that have not recovered from adverse events due to chemotherapy agents administered more than 4 weeks earlier.
* Hypersensitivity to copanlisib or romidepsin or any of its excipients.
* Patients that received major su…
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.