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 range18 Years
SexALL
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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…
What they're measuring
1
Phase I: Maximum Tolerated Dose (MTD)
Timeframe: From first dose of treatment through the 1st cycle (28 days)