Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome (NCT05944562) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome
United States24 participantsStarted 2024-01-09
Plain-language summary
The hypotheses of this study are that single agent DZR123 will be safe and well tolerated in patients with advanced (stage IB-IVB) mycosis fungoides (MF)/Sézary syndrome (SS) who have had at least one prior systemic therapy, and that in these patients, DZR123 will demonstrate efficacy and be worth of further study.
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:
* Histologically or cytologically confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB with measurable disease and/or detectable blood involvement based on the Global Response Criteria for CTCL (Olsen et al., 2022).
* Received at least one prior line of systemic therapy.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Adequate counts and organ function as defined below:
* ANC ≥ 0.7 x 109/L, without growth factor support (filgrastim or pegfilgrastim) for at least 14 days
* Platelets ≥ 75 x 109/L, without platelet transfusion for at least 14 days
* Hemoglobin ≥ 8.0 g/dL, with or without transfusion
* Serum total bilirubin ≤ 1.5 x IULN
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
* Creatinine clearance \> 30 mL/min by Cockcroft-Gault (using actual body weight) for patients with creatinine levels above institutional normal OR serum creatinine ≤ 1.5 x ULN
* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression.
* The effects of DZR123 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 183 days after the last dose of DZR123 for female patients and female partners of male patients, or for 93 days after the last dose of DZR123 for male patients and male partners of female patients. Should a woman be…
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.
1Since this is a Phase 1 trial primarily focused on measuring how often and how severely side effects occur with tulmimetostat, what does that mean for what we actually know so far about whether it helps treat my mycosis fungoides or Sézary syndrome?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — so is there any chance I could still access this drug through a compassionate use or expanded access program?
3Given that the main thing being tracked is treatment-related adverse events and how many people have to stop treatment because of side effects, what kinds of safety concerns have been seen so far, and how do they compare to the side effects of my current or standard treatment options?
4Since this is a first-in-human style safety study for a drug called tulmimetostat, how would you weigh the unknowns of this experimental approach against established treatments for my stage of mycosis fungoides or Sézary syndrome?
5Are there other active clinical trials for mycosis fungoides or Sézary syndrome that are still enrolling and might be worth considering alongside or instead of this one?
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.
What they're measuring
1
Frequency and grades of treatment-emergent adverse events (TEAE)
Timeframe: From start of treatment through 30 days after completion of treatment (estimated to be 13 months)
2
Rate of treatment discontinuation due to treatment-emergent adverse events (TEAE)
Timeframe: From start of treatment through 30 days after completion of treatment (estimated to be 13 months)