Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell … (NCT02223208) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas
Italy89 participantsStarted 2014-09
Plain-language summary
This is a multicenter study that includes two phases:
1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study.
2. A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ≥18 e ≤ 65 years
✓. Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS, AITL including other nodal TFH, ALK-ALCL
✓. Stage II-IV
✓. Written informed consent
✓. No prior treatment for lymphoma
✓. No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
✓. HIV negativity
✓. Absence of active hepatitis C virus (HCV) infection
Exclusion criteria
✕. Age \<18 e \> 65 years
✕. Hystology other than: PTCL-NOS, AITL, ALK-ALCL
✕. Stage I
✕
What they're measuring
1
Dose-limiting toxicity (DLT) of Ro-CHOEP-21 (Phase I endpoint)
Timeframe: 3 months
2
Progression Free Survival (PFS) of Ro-CHOEP-21 (Phase II endpoint)