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Phase 2
Not Enrolling
Peripheral T Cell Lymphoma (PTCL)

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Trial Information

Inclusion Criteria:

Written informed consent/ authorization Patient has completed 6 cycles of therapy in a
prior Gloucester-sponsored depsipeptide clinical trial Patient has immediate past
participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a
prior Gloucester-sponsored depsipeptide clinical trial Patient has demonstrated stable
disease, partial response or complete response as best overall response in their prior
Gloucester-sponsored depsipeptide clinical trial and such response must be ongoing at the
time of enrollment Patient must have serum potassium levels >4.0mEq/L and serum magnesium
levels >2.0mg/dL Negative urine or serum pregnancy test on females of childbearing
potential Sexually active females of child-bearing potential must be willing to practice
reliable methods of birth control to prevent pregnancy after entering the trial Sexually
active males must be willing to practice reliable methods of birht control after entering
the trial

Exclusion Criteria:

Patients wiht known cardiac abnormalities such as

- congenital long QT syndrome

- QTc interval >480 milliseconds Patients with any cardiac arrhythmia requiring
anti-arrhythmic medication Patients who have had a history of coronary artery disease
(CAD) eg. angina Canadian class II-IV (see appendix G)> In any patient whom there is
doubt, the patient should have a stress imaging study and, if abnormal, angiopathy to
define whether or not CAD is present Patients who have had a myocardial infarction
within 12 months of study entry. Patients with an ECG recorded at screening showing
evidence of cardiac ishemia (ST depression of >2mm). If in any doubt, the patient
should have a stress imaging study and if abnormal, angiograpphy to define whether or
not CAD is present Patients with congestive heart failure that meets New York heart
Association (NYHA) Class II to IV (see appendix F) definitions and/or ejection
fraction <40% by MUGA scan or <50% by echocardiogram and/or magnetic resonance
imaging (MRI) Patients with a history of sustained VT,VF,Torsade de Pointes, or
cardiac arrest unless currently addressed with an automatic implantable cardioverter
defibrillator (AICD) Patients with a hypertrophic cardiomelagy or restrictive
cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction
criteria above) Patients with uncontrolled hypertension ie > 160/95 Concomitant use
of medications which may cause a prolongation of QT/QTc Concomitant use of
medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 Absolute
neutrophil count (ANC) < 1.5 X 109 cells/L Platelet count <75 x 109 cells/L Serum
creatinine concentration >2 mg/dL or creatinine clearance <40mL/min AST (aspartate
aminotransferase ) and alanine aminotransferase (ALT) >2.0 x ULN or >5 X ULN in
presence of demonstable liver metastasis Bilirubin concentration > 1.25 x ULN or >
2.0 x ULN in presence of demonstrable liver metastases Serum potassium <4.0mEq/L and
serum magnesium <2.0 mg/dL Failure to recover of any drug-related non-hematological
toxicity to grade 1 oe less or to baseline values unless otherwise indicated
Concomitant use of warfarin (due to a potentialdrug to drug interaction with
depsipeptide) Patient is pregnant or nursing Patient had been on prior
Gloucester-sponsored depsipeptide clinical trial, left the trial and then received
alternative neoplastic therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Dr Johann De Bono

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Peripheral T Cell Lymphoma (PTCL)
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral