Trials / Active Not Recruiting

Active Not RecruitingNCT02223208

Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas

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

Status: Active Not Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 89 (actual)

Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

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.

Detailed description

PHASE I A1) Induction phase Ro-CHOEP-21 x 3 cycles * Romidepsin (dose escalation) starting dose: 12mg/ms iv day +1 and +8. Dose modification according to toxicity (14mg/ms day +1 and +8; 10mg/ms day +1 and +8; 8mg/ms day +1 and +8); * CHOEP-21 (Doxorubicin 50 mg/ms iv day +1; Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1; Cyclophosphamide 750 mg/ms iv day +1; Etoposide 100mg/ms iv from day +1 to +3; Prednisone100 mg orally from days +1 to +5). According to the response achieved after the first 3 Ro-CHOEP-21 cycles: * PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by phase A2 * SD or PD: Treatment failures, proceed to salvage according to each institutional policy. A2) Stem cell mobilization and transplantation phase Response evaluation and one DHAP course followed by peripheral stem cell harvesting. According to response achieved after 6 Ro-CHOEP-21 cycles: CR: BEAM or FEAM or CEAM followed by auto-SCT PR * Allogeneic SCT with HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors. Donor selection is based on molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA-A, B, and C) and class II (DRB1, DQB1). In case, no class I and class II completely identical urelated donor (10 out of 10 gene loci) can be identified, the degree of histocompatibility between patient and donor must fulfill with the minimal degree of matching established by the Italian Bone Marrow Donor Registry: HLA-A and HLA-B antigen histocompatibility and HLA-DRB1 allelic histocompatibility. * when a suitable donor is not available: BEAM or FEAM or CEAM followed by Auto-SCT. * Haploidentical transplantation is allowed in selected cases \< PR: Treatment failures, proceed to salvage according to each institutional policy. PHASE II A1) Induction phase Ro-CHOEP-21 x 3 cycles * Romidepsin dose according to phase I iv day +1 and +8 * Doxorubicin 50 mg/ms iv day +1, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1, * Cyclophosphamide 750 mg/ms iv day +1, * Etoposide 100mg/ms iv from day +1 to +3 * Prednisone100 mg orally from days +1 to +5 According to the response achieved after the first 3 Ro-CHOEP-21 cycles: * PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by phase A2 * SD or PD: Treatment failures, proceed to salvage according to each institutional policy. A2) Stem cell mobilization and transplantation phase Response evaluation and one DHAP course followed by peripheral stem cell harvesting. According to response achieved after 6 Ro-CHOEP-21 cycles: CR: BEAM or FEAM or CEAM followed by auto-SCT PR * Allogeneic SCT with HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors. Donor selection is based on molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA-A, B, and C) and class II (DRB1, DQB1). In case, no class I and class II completely identical urelated donor (10 out of 10 gene loci) can be identified, the degree of histocompatibility between patient and donor must fulfill with the minimal degree of matching established by the Italian Bone Marrow Donor Registry: HLA-A and HLA-B antigen histocompatibility and HLA-DRB1 allelic histocompatibility. * when a suitable donor is not available: BEAM or FEAM or CEAM followed by Auto-SCT. * Haploidentical transplantation is allowed in selected cases \< PR: Treatment failures, proceed to salvage according to each institutional policy.

Conditions

Interventions

Type	Name	Description
DRUG	Ro-CHOEP-21 (PHASE I)	Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8 Dose modification according to toxicity: * 14mg/ms day +1 and +8 * 10mg/ms day +1 and +8 * 8mg/ms day +1 and +8 CHOEP-21 * Doxorubicin 50 mg/ms iv day +1 or +2, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2 * Cyclophosphamide 750 mg/ms iv day +1 or +2 * Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4 * Prednisone100 mg orally from days +1 to +5 or from days +2 to +6 PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)
DRUG	Ro-CHOEP-21 (PHASE II)	Ro-CHOEP-21 x 3 cycles * Romidepsin dose according to phase I iv day +1 and +8 * Doxorubicin 50 mg/ms iv day +1 or +2, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2, * Cyclophosphamide 750 mg/ms iv day +1 or +2 * Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4 * Prednisone100 mg orally from days +1 to +5 or from days +2 to +6 PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)

Timeline

Start date: 2014-09-01
Primary completion: 2020-10-01
Completion: 2026-02-01
First posted: 2014-08-22
Last updated: 2025-12-02

Locations

27 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT02223208. Inclusion in this directory is not an endorsement.