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A Japanese Phase 1/2, Multicenter, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Romidepsin in Subjects With the Progressive or Relapsed Peripheral T-cell Lymphoma

Phase 1/Phase 2
20 Years
Open (Enrolling)
Lymphoma, T-cell, Peripheral

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Trial Information

A Japanese Phase 1/2, Multicenter, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Romidepsin in Subjects With the Progressive or Relapsed Peripheral T-cell Lymphoma

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study participation
and have:

- Histologically confirmed Peripheral T cell Lymphoma (PTCL) Not Otherwise Specified
(NOS), Angioimmunoblastic T-cell Lymphoma, extranodal Natural Killer/T-cell lymphoma
nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell
lymphoma, cutaneous T-cell lymphoma (excludes mycosis fungoides or Sezary syndrome) ,
hepatosplenic T-cell lymphoma, Anaplastic Large cell lymphoma (ALCL) [anaplastic
lymphoma kinase-1 (ALK-1) negative], patients with ALK 1 expressing ALCL (ALK-1
positive) who have relapsed disease after Autologous Stem-Cell Transplantation,
mycosis fungoides (MF) or Sézary syndrome (SS);

- Age ≥20 years;

- Written informed consent;

- Progressive Disease following at least one systemic therapy or refractory to at least
one prior systemic therapy;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

- Sufficient functions of bone marrow or other organs as evidenced by

- Hemoglobin ≥9.0 g/dL

- Absolute neutrophil count (ANC) ≥1.0×109/L

- Platelet counts ≥100 x 109/L, or, if bone marrow infiltration is recognized, ≥75

- Total bilirubin (Total-Bil) ≤2 x upper limit of normal (ULN) (≤3.0 x ULN in the
presence of demonstrable liver metastasis)

- Aspartate Aminotransferase (AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT)
≤2 x Upper Limit Normal (ULN) (≤3.0 x ULN in the presence of demonstrable liver

- Alanine Aminotransferase (ALT)/Serum Glutamic-Oxaloacetic Transaminase (SGOT) ≤2
x ULN (≤3.0 x ULN in the presence of demonstrable liver metastasis)

- Serum creatinine ≤ 2 x ULN

- Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L;

- Patients for whom at least 1 measurable lesion is confirmed in the lesion
assessment before enrollment; and

- Negative urine or serum pregnancy test on females of childbearing potential.

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

- Known Central Nervous System (CNS) lymphoma;

- Chemotherapy or immunotherapy within 4 weeks of study entry;

- Use of any investigational agent within 4 weeks of study entry;

- Clinically significant active infection

- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.

- Patient with a history of hematological malignant tumor (other than T-cell lymphoma)

- Use of topical steroids within 2 weeks (Use of steroids for the purpose other than
that of treatment of the target disease should be allowed);

- Use of systemic steroids within 4 weeks (It is acceptable to continue the use of the
steroid for the purpose of treatment of the target disease, which administered in
doses ≤ 10mg/day prednisolone or equivalent dose of other glucocorticoid);

- Use of radiation therapy, psoralen + UVA (PUVA) therapy or Total Skin Electron Beam
(TSEB) for the purpose of treatment of the target disease within 4 weeks;

- Use of other investigational products in the previous 4 weeks (using antibody drugs
only in the previous 3 months);

- Use of blood transfusion and using G-CSF within 2 weeks;

- Any known cardiac abnormalities such as:

- Congenital long QT syndrome;

- QTc interval >480 milliseconds (msec);

- Myocardial infarction within 6 months before C1D1. Patients with a history of
myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic
and have had a negative cardiac risk assessment (treadmill stress test, nuclear
medicine stress test, or stress echocardiogram) since the event may occur;

- Significant ECG abnormalities including atrio-ventricular (AV) block type II,
3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);

- Symptomatic coronary artery disease (CAD) (e.g., Angina Canadian Class II-IV);

- An ECG recorded at screening showing significant ST depression (ST depression of
≥2 mm, measured from isoelectric line to the ST segment at a point 60 msec at
the end of the QRS complex). If there is any doubt, the subject should have a
stress imaging study and, if abnormal, angiography to define whether or not CAD
is present;

- Congestive heart failure (CHF) that meets New York Heart Association (NYHA)
Class II to IV definitions and/or ejection fraction <40% by MUGA scan or <50% by
echocardiogram and/or MRI;

- 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);

- Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment
or other causes (if there is any doubt, see ejection fraction criteria above);

- Uncontrolled hypertension, i.e., systolic blood pressure (BP) is greater than or
equal to 160 mmHg or diastolic BP is greater than or equal to 95 mmHg; subjects
who have a history of hypertension controlled by medication must be on a stable
dose (for at least one month);

- Any cardiac arrhythmia requiring anti-arrhythmic medication;

- Concomitant use of drugs that may cause a significant prolongation of the QTc;

- Concomitant use of CYP3A4 significant or moderate inhibitors which include grapefruit

- Concomitant use of therapeutic warfarin or another anticoagulant due to a potential
drug interaction. Use of a small dose of a anticoagulant to maintain patency of
venous access port and cannulas is permitted;

- Previous extensive radiotherapy involving ≥30% of bone marrow, excluding patients who
have had total body irradiation as part of a conditioning regimen for ASCT;

- Major surgery within 2 weeks of study entry. However, even if more than 15 days have
passed since the surgery, subjects without evidence of wound healing will be

- Patients who are during recovery process from severe wound or fracture;

- Previous allogeneic stem cell transplant;

- Patients who are pregnant or breast-feeding;

- Patients with a history of any other malignant tumor or solid cancer within previous
3 years (excluding basal or squamous cell carcinoma of skin, and in situ carcinoma of
the cervix (CIN3) that has been treated curatively);

- Patients for whom transfusion of red blood cells or platelets is impossible; or

- Prior exposure to Romidepsin (other histone deacetylase inhibitors are allowed).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Masamitsu Harata

Investigator Role:

Study Director

Investigator Affiliation:

Celgene K.K.


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

October 2011

Completion Date:

December 2015

Related Keywords:

  • Lymphoma, T-Cell, Peripheral
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral