Overview

This trial is active, not recruiting.

Condition peripheral t-cell lymphoma
Treatment romidepsin, gemcitabine
Phase phase 2
Sponsor Fondazione Italiana Linfomi ONLUS
Start date January 2013
End date December 2014
Trial size 20 participants
Trial identifier NCT01822886, FIL_GEMRO

Summary

Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL in a selected population of patients.

Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD
romidepsin, gemcitabine
Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.

Primary Outcomes

Measure
CR rate
time frame: 18 months

Secondary Outcomes

Measure
ORR
time frame: 30 months
DOR
time frame: 30 months
PFS
time frame: 30 months
OS
time frame: 30 months
B-symptoms
time frame: 30 months
Safety
time frame: 30 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with histological diagnosis of PTCL according to the WHO classification - Age ≥ 18 years - Relapsed (≥1) or refractory to conventional chemotherapy/radiotherapy - Stage I-IV according to the Ann Arbor staging System - ECOG Performance status ≤2 - Normal renal and hepatic functions - Laboratory test results as follows: - Serum creatinine ≥ 2.0 mg/dL - Total bilirubin ≥ 1.5 mg/dL - AST (SGOT) and ALT (SGPT) £2 x ULN or £5 x ULN if hepatic metastases are present - Negative HIV HCV and HBV status - Adequate bone marrow reserve: Platelet count>100X109 cells/L or platelet count <75X109 cells/L if bone marrow disease involvement, absolute neutrophile count (ANC)> 1,5 X109, hemoglobin>8 g/dl. - Able to adhere to the study visit schedule and other protocol requirements - Cardiac ejection fraction (MUGA scan or echocardiography) > 45% - Life expectancy > 6 months - Females of childbearing potential (FCBP) must have a negative serum or urine β-hCG pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy - Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug. - Measurable disease of at least 2 cm as detected by CT scan, assessed by site radiologist - Patients or they legally authorized representative must provide written informed consent Exclusion Criteria: - Any serious active disease or co-morbid medical condition (according to investigator's decision) - Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form - Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation - Corrected QT interval > 480 msec (using the Fredericia formula) - Low K+ (<3.8 mmol/L) and low Mg+ (<0.85 mmol/L) levels, except if corrected before beginning the chemotherapy - Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study - Previous exposure to romidepsin or gemcitabine - CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement - History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances - Active opportunistic infection

Additional Information

Official title Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
Principal investigator Pier Luigi Zinzani
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Fondazione Italiana Linfomi ONLUS.