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A Phase II, Multicenter, Open-Label Trial Evaluating the Activity and Tolerability of Romidepsin (Depsipeptide, FK228) in Progressive or Relapsed Peripheral T-cell Lymphoma Following Prior Systemic Therapy

Phase 2
18 Years
Open (Enrolling)
Peripheral T-cell Lymphoma

Thank you

Trial Information

A Phase II, Multicenter, Open-Label Trial Evaluating the Activity and Tolerability of Romidepsin (Depsipeptide, FK228) in Progressive or Relapsed Peripheral T-cell Lymphoma Following Prior Systemic Therapy

Inclusion Criteria:

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

- Histologically confirmed PTCL not otherwise specified, angioimmunoblastic T-cell
lymphoma, extranodal natural killer (NK)/T-cell lymphoma nasal type, enteropathy-
type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous γδ
T-cell lymphoma (excludes mycosis fungoides or Sezary syndrome), transformed mycosis
fungoides, hepatosplenic T-cell lymphoma, anaplastic large cell lymphoma (ALCL;
anaplastic lymphoma kinase [ALK]-1 negative), or patients with ALK 1 expressing ALCL
(ALK-1 positive) who have relapsed disease after autologous stem cell transplant

- Age ≥18 years;

- Written informed consent;

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

- Measurable disease according to the International Workshop Response (IWC) criteria
and/or measurable cutaneous disease;

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

- Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L (electrolyte abnormalities can
be corrected with supplementation to meet inclusion criteria);

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

- All women of childbearing potential must use an effective barrier method of
contraception (either an intrauterine contraceptive device [IUCD] or double barrier
method using condoms or a diaphragm plus spermicide) during the treatment period and
for at least 1 month thereafter. Male patients should use a barrier method of
contraception during the treatment period and for at least 1 month thereafter.
Hormonal methods of contraception such as the contraceptive pill or patch
(particularly those containing ethinyl-estradiol) should be avoided due to a
potential drug interaction.

Exclusion Criteria:

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

- Known central nervous system (CNS) lymphoma [computed tomography (CT) or magnetic
resonance imaging (MRI) scans are required only if brain metastasis is suspected

- Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas

- Initiation of corticosteroids during study (defined as 7 days prior to Cycle 1 Day
1[C1D1] until study drug discontinuation)

- Patients treated with a pulse of steroids were to discontinue steroid use 7 days
prior to C1D1 and have a repeat CT scan and disease assessment after
discontinuation of corticosteroids and before starting romidepsin;

- Concomitant use of any other anti-cancer therapy;

- Concomitant use of any investigational agent;

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

- Any known cardiac abnormalities such as:

- Congenital long QT syndrome;

- QTc interval >480 milliseconds (msec);

- A myocardial infarction within 6 months of C1D1. Patients with a history of
myocardial infraction 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 participate;

- Other significant electrocardiogram (ECG) abnormalities including 2nd degree
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.
In any patient in whom there is doubt, the patient should be referred to a
cardiologist for evaluation;

- 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 in any doubt, the patient should have a stress
imaging study and, if abnormal, angiography to define whether or not CAD is

- 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 in doubt, see ejection fraction criteria above);

- Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who
have a history of hypertension controlled by medication must be on a stable dose
(for at least one month) and meet all other inclusion criteria;

- Any cardiac arrhythmia requiring anti-arrhythmic medication;

- Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (electrolyte
abnormalities can be corrected with supplementation to meet inclusion criteria);

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

- Concomitant use of CYP3A4 significant or moderate inhibitors;

- 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;

- Clinically significant active infection;

- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;

- Previous extensive radiotherapy involving ≥30% of bone marrow (e.g., whole pelvis,
half spine), excluding patients who have had total body irradiation as part of a
conditioning regimen for ASCT;

- Major surgery within 2 weeks of study entry;

- Previous allogeneic stem cell transplant;

- Inadequate bone marrow or other organ function as evidenced by:

- Hemoglobin <9 g/dL (transfusions and/or erythropoietin are permitted);

- Absolute neutrophil count (ANC) ≤1.0 × 10^9 cells/L [patients with neutropenia
(ANC 1-1.5 10^9 cells/L) as a function of their disease may be supported with
granulocyte-colony stimulating factor (G-CSF)];

- Platelet count <100 × 10^9 cells/L or platelet count <75 × 10^9 cells/L if bone
marrow disease involvement is documented;

- Total bilirubin >2.0 × upper limit of normal (ULN) or >3.0 × ULN in the presence
of demonstrable liver metastases;

- Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and
alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 × ULN
or >3.0 × ULN in the presence of demonstrable liver metastases; or

- Serum creatinine >2.0 × ULN;

- Patients who are pregnant or breast-feeding;

- Coexistent second malignancy or history of prior solid organ malignancy within
previous 3 years (excluding basal or squamous cell carcinoma of the skin, and in situ
carcinoma of the cervix (CIN 1) that has been treated curatively);

- Any prior history of a hematologic malignancy (other than T-cell lymphoma);

- Any significant medical or psychiatric condition that might prevent the patient from
complying with all study procedures; 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:

Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee

Outcome Description:

Complete Response (CR): >75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed >75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by >75% in their SPD.

Outcome Time Frame:

Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).

Safety Issue:


Principal Investigator

Jean Nichols, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Peripheral T-cell Lymphoma
  • peripheral T-cell lymphoma
  • T-cell lymphoma
  • romidepsin
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral



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Northwest Cancer Specialists Portland, Oregon  97225
Rush University Chicago, Illinois  60612
UT Southwestern Medical Center, Simmons Comprehensive Cancer Center Dallas, Texas  
University of California at San Diego - Moore Cancer institute La Jolla, California  92093
UCLA Medical Center Division for Oncology and Hematology Los Angeles, California  90095
Rocky Mountain Cancer Center-12 locations in CO Denver, Boulder, Aurora, Colorado Springs, etc., Colorado  80909
Winship Cancer Institute - Emory University Atlanta, Georgia  30322
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Center for Cancer Research National Cancer Institute Bethesda, Maryland  20892
Nebraska Methodist Hospital, Eastbrook Cancer Center Omaha, Nebraska  68114
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