E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Progressive or Relapsed Peripheral T-Cell Lymphoma following Prior Systemic Therapy |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034625 |
E.1.2 | Term | Peripheral T-cell lymphoma unspecified recurrent |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) following prior systemic therapy. The rate of complete response [CR + CR(u)] will be used as the primary endpoint to assess efficacy. |
|
E.2.2 | Secondary objectives of the trial |
To estimate objective disease response rate [CR + CR(u) + PR]; To estimate the duration of response; To estimate the time to disease progression; To assess the tolerability and safety of romidepsin; and To estimate the change in ECOG performance status. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically confirmed PTCL NOS, angioimmunoblastic T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous  T-cell lymphoma (excludes mycosis fungoides or Se`zary syndrome), transformed mycosis fungoides, hepatosplenic T-cell lymphoma, ALCL (ALK-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after ASCT; Age ≥18 years; Progressive disease following at least one systemic therapy or refractory to at least one prior systemic therapy; Measurable disease according to the IWC criteria and/or measurable cutaneous disease; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix C); Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L Negative urine or serum pregnancy test on females of childbearing potential; and All women of childbearing potential must use an effective barrier method of Male patients should use a barrier method of contraception during the treatment period and for at least 3 months thereafter. |
|
E.4 | Principal exclusion criteria |
Known central nervous system (CNS) lymphoma [computed tomography (CT) or magnetic resonance imaging (MRI) scans are required only if brain metastasis is suspected clinically]; Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas given); Initiation of corticosteroids during study Concomitant use of any other anti-cancer therapy; Any known cardiac abnormalities such as: o Congenital long QT syndrome; o QTc interval >480 milliseconds (msec); o Myocardial infarction within 6 months of C1D1. o Other significant ECG abnormalities.. o Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV o Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV; o A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD); o Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes o Uncontrolled hypertension o Any cardiac arrhythmia requiring anti-arrhythmic medication; Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L Concomitant use of drugs that may cause a significant prolongation of the QTc or use of CYP3A4 significant or moderate inhibitors Concomitant use of therapeutic warfarin or another anticoagulant Clinically significant active infection; Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; Previous extensive radiotherapy; Major surgery within 2 weeks of study entry (C1D1); Previous allogeneic stem cell transplant; Inadequate bone marrow or other organ function. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter is rate of complete response, defined as the proportion of patients with complete response (CR) and unconfirmed complete response [CR(u)]. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |