Status:
COMPLETED
A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma
Lead Sponsor:
Celgene
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.
Detailed Description
This is a Phase II, non-randomized, open-label, single-arm trial. This study is designed on the basis of complete response (CR) or unconfirmed CR \[CR(u)\] as the measure of efficacy, based on the bes...
Eligibility Criteria
Inclusion
- 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 (ASCT);
- 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
- Patients are ineligible for entry if any of the following criteria are met:
- Known central nervous system (CNS) lymphoma \[computed tomography (CT) or magnetic resonance imaging (MRI) scans are required only if brain metastasis is suspected clinically\];
- Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas given);
- 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 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 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).
Key Trial Info
Start Date :
June 19 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2018
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00426764
Start Date
June 19 2007
End Date
May 17 2018
Last Update
February 11 2020
Active Locations (90)
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1
Moore UCSD Cancer Center
La Jolla, California, United States, 92093
2
UCLA Division of Hematology Oncology
Los Angeles, California, United States, 90095
3
University of California, San Francisco
San Francisco, California, United States, 94143-0324
4
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012