Clinical Trial: Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study
Brief Summary:
This is a multicenter study that includes two phases:
- 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.
- 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.
Detailed Summary:
Sponsor: Fondazione Italiana Linfomi ONLUS
Current Primary Outcome:
- Dose-limiting toxicity (DLT) of Ro-CHOEP-21 (Phase I endpoint) [ Time Frame: 3 months ]Incidence of dose-limiting toxicity (DLT) of Ro-CHOEP-21, considering as maximum dose the one causing induction of any grade ≥ 3 non hematologic toxicity or a delay >15 days of planned cycle date observed during the first two cycles according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)
- Progression Free Survival (PFS) of Ro-CHOEP-21 (Phase II endpoint) [ Time Frame: 18 months ]PFS on intention to treatment (ITT) evaluated at 18 months. PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients reaching SCT (Phase I endpoint) [ Time Frame: 6 months ]Proportion of patients reaching SCT
- ORR = Overall response rate (Phase I endpoint) [ Time Frame: 6 months ]Overall response rate (ORR, defined according to the Cheson 2007 response criteria) of the combination of Ro-CHOEP-21.
- Overall Response Rate (ORR) and Complete Response (CR)(Phase II endpoint) [ Time Frame: 6 months ]ORR and CR (defined according to the Cheson 2007 response criteria), after induction treatment and after SCT.
- Event free survival (EFS) (Phase II endpoint) [ Time Frame: 18 months ]Event free survival (EFS) defined as the time between the date of enrollment and the date of discontinuation of treatment for any reason
- Overall survival (OS) (Phase II endpoint) [ Time Frame: 24 months ]Overall survival (OS) defined as the time between the date of enrolment and the date of death from any cause in the ITT population enrolled in the study
- Progression Free Survival (PFS) and Overall Survival (OS) (Phase II endpoint) [ Time Frame: 3 months ]PFS and OS in patients not responding to the first 3 courses of Ro-CHOEP-21
- Toxicities (Phase II endpoint) [ Time Frame: 18 months ]Evaluation during the interim analyses of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)
- Higher toxicities (Phase II endpoint) [ Time Frame: 18 months ]Evaluation during all the pretransplant phase of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)
- Treatment-related mortality (TRM) (Phase II Endpoint) [ Time Frame: 24 months ]Treatment-related mortality defined as any death that was not attributable to the lymphoma.
- Graft-versus-host disease (GVHD) (Phase II endpoint) [ Time Frame: 24 months ]Incidence of acute and chronic GVHD in allografted patients
Original Secondary Outcome:
- Proportion of patients reaching SCT (Phase I endpoint) [ Time Frame: 6 months ]Proportion of patients reaching SCT
- ORR = Overall response rate (Phase I endpoint) [ Time Frame: 6 months ]Overall response rate (ORR, defined according to the Cheson 2007 response criteria) of the combination of Ro-CHOEP-21.
- Overall Response Rate (ORR) and Complite Response (CR)(Phase II endpoint) [ Time Frame: 6 months ]ORR and CR (defined according to the Cheson 2007 response criteria), after induction treatment and after SCT.
- Event free survival (EFS) (Phase II endpoint) [ Time Frame: 18 months ]Event free survival (EFS) defined as the time between the date of enrollment and the date of discontinuation of treatment for any reason
- Overall survival (OS) (Phase II endpoint) [ Time Frame: 24 months ]Overall survival (OS) defined as the time between the date of enrolment and the date of death from any cause in the ITT population enrolled in the study
- Progression Free Survival (PFS) and Overall Survival (OS) (Phase II endpoint) [ Time Frame: 3 months ]PFS and OS in patients not responding to the first 3 courses of Ro-CHOEP-21
- Toxicities (Phase II endpoint) [ Time Frame: 18 months ]Evaluation during the interim analyses of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)
- Higher toxicities (Phase II endpoint) [ Time Frame: 18 months ]Evaluation during all the pretransplant phase of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)
- Treatment-related mortality (TRM) (Phase II Endpoint) [ Time Frame: 24 months ]Treatment-related mortality defined as any death that was not attributable to the lymphoma.
- Graft-versus-host disease (GVHD) (Phase II endpoint) [ Time Frame: 24 months ]Incidence of acute and chronic GVHD in allografted patients
Information By: Fondazione Italiana Linfomi ONLUS
Dates:
Date Received: July 21, 2014
Date Started: September 2014
Date Completion: March 2023
Last Updated: February 14, 2017
Last Verified: February 2017
