NCT01738594.

Study name	A randomized phase I dose‐escalation trial of carfilzomib with and without romidepsin in cutaneous T‐cell lymphoma
Methods	This is a randomised, controlled trial on carfilzomib with and without romidepsin in patients with cutaneous T‐cell lymphoma
Participants	Inclusion criteria Patients must have histological confirmation of a cutaneous T‐cell lymphoma (CTCL) of any histology; confirmation of histological diagnosis must be completed prior to enrolment by the lead site (Northwestern) Patients will be stratified by mycosis fungoides (MF) and Sezary syndrome (SS) (report diagnostic or consistent with MF/SS), stage IA‐IVB according to TNM blood (TNMB) classification versus other CTCL histologies Patients must have measurable disease (using modified Severity‐Weighted Assessment Tool (mSWAT)) and/or use of indicator lesions must be designated prior to study enrolment (from imaging); measurable disease upon physical exam with a negative scan is acceptable Patients with MF/SS must have failed at least 1 prior topical therapy (including steroids, nitrogen mustard, retinoids, phototherapy, photochemotherapy, radiation, and total skin electron beam); there is no upper limit for prior therapies Exclusion criteria Patients who have received topical therapy, systemic chemotherapy, or biological therapy within 4 weeks prior to registration are not eligible for participation
Interventions	Arm I Patients receive carfilzomib IV over 2‐10 minutes on days 1, 2, 8, 9, 15, and 16 Arm II Patients receive carfilzomib as in Arm A and romidepsin IV over 4 hours on days 1, 8, and 15
Outcomes	Primary outcomes of the trial Evaluate toxicity by assessing the adverse events of carfilzomib alone and when taken with romidepsin To determine the maximum tolerated dose (MTD) by assessing the adverse events of both carfilzomib alone and when taken with romidepsin in evaluating toxicity on days 1 and 15 of each cycle of treatment Secondary outcomes of the trial Overall response rate (ORR) of the disease when treated with carfilzomib alone and when taken with romidepsin Response will be categorised as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The ORR of the study treatment will be evaluated based on skin biopsy, computerised tomography (CT) scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles). Duration of response of the disease when treated with carfilzomib alone and when taken with romidepsin Duration of response will be defined as the time from the point at which response is achieved until the point of disease progression. The duration of response of the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles) Time to progression of the disease when treated with carfilzomib alone and when taken with romidepsin The time to progression will be measured as the time from the first dose of study therapy until the point at which disease is determined to have progressed or patients discontinue therapy for toxicity. To measure time to progression, the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles)
Starting date	January 2013
Contact information	Sponsors and collaborators Northwestern University Investigators Principal investigator: Timothy Kuzel, Northwestern University
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