Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) (NCT03547700) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
Stopped: Lack of accrual
United States11 participantsStarted 2018-09-26
Plain-language summary
Single arm phase I/II study of ixazomib and romidepsin in relapsed/refractory PTCL. Each cycle is 28 days. Patients will continue to receive therapy until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. The phase I study includes three dose levels. The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I 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:
* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
* Age ≥ 18 years at the time of consent.
* ECOG Performance Status of 0-2 within 14 days prior to registration.
* Histological confirmation of peripheral T-cell lymphoma (PTCL) and biopsy confirmation of disease relapse (after initial or any subsequent salvage therapy).
* Documented disease progression after receiving at least one prior therapeutic regimen.
* Prior cancer treatment must be completed at least 28 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. Systemic steroids at a dose less than the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are permitted. Intermittent dexamethasone for the treatment of nausea/emesis is also permitted.
* Absolute Neutrophil Count (ANC) ≥ 1000/mm3
* Platelets (Plt) ≥ 75,000/mm3
* Calculated creatinine clearance ≥ 30 cc/min using the Cockcroft-Gault formula
* Bilirubin ≤ 1.5 × upper limit of normal (ULN), (exception of Gilbert disease)
* Aspartate aminotransferase (AST) ≤ 3 × ULN, if known hepatic involvement then ≤ 5 × ULN
* Alanine aminotransferase (ALT) ≤ 3 × ULN, if known hepatic involvement then ≤ 5 × ULN
* Females of childbearing potential must have a negative serum pregnancy test with…
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.
1This trial was terminated before it finished — can you tell me why it was stopped early, and what that means for what we know about whether ixazomib and romidepsin are safe or effective for peripheral T-cell lymphoma?
2Since this study was in Phase 1/2, it was still in early stages of figuring out the right dose and whether the treatment works — does that mean there are other, more established treatment options I should consider first given how early this research is?
3The trial was measuring complete response rate as its main goal in Phase 2, but since it was terminated, do we have any partial data from the patients who did participate that my care team could look at when thinking about my options?
4Are there other currently active clinical trials for peripheral T-cell lymphoma that you'd recommend I look into, now that this one is no longer enrolling?
5Given that this trial combined two drugs — ixazomib and romidepsin — is either of those drugs being studied in other trials or used in standard care for PTCL that might still be relevant to my situation?
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
Phase I: Maximum Tolerated Dose (MTD)
Timeframe: From first dose of treatment through the 1st cycle (28 days)