Peripheral T-Cell Lymphoma MedDRA version: 21.1 Level: PT Classification code 10034623 Term: Peripheral T-cell lymphoma unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Istodax
Product Name: romidepsin
Product Code: FK228
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: ROMIDEPSIN
CAS Number: 128517-07-7
Concentration
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy all following criteria to be enrolled in the study: 1. Males and females of 18 years of age to 80 years of age. 2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the WHO classification (2008;2011) may be included, whatever the Ann Arbor stage (l-lV): a. Nodal types: i. PTCL, not otherwise specified ii. Angioimmunoblastic T-cell lymphoma iii. Anaplastic large cell lymphoma, ALK-negative type b. Extra-nodal types: i. Enteropathy-associated T-cell lymphoma ii. Hepato-splenic T-cell lymphoma iii. Subcutaneous panniculitis-like T-cell lymphoma iv. Primary cutaneous gamma-delta T-cell lymphoma v. Primary cutaneous CD8+ aggresive epidermotropic lymphoma vi. Primary cutaneous CD4+ small/medium T-cell lymphoma c. Other non classifiable peripheral T-cell lymphoma 5. ECOG performance status 0, 1 or 2 6. Negative pregnancy test for females of childbearing potential (FCBP) 7. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter. 8. Life expectancy of = 90 days (3 months). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a patient from enrollment: 1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study. 2. Any condition that confounds the ability to interpret data from the study. 3. Other types of lymphomas, e.g. B-cell lymphoma. 4. The following types of T cell lymphomas: a. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma) b. Extranodal T-cell/NK-cell lymphoma, nasal type c. Anaplastic large cell lymphoma, ALK-positive type d. Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome) e. Primary cutaneous CD30+ T-cell lymphoproliferative disorder f. Primary cutaneous anaplastic T-cell lymphoma 5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of 2 x ULN, except in case of hemolytic anemia, e. K+ and Mg2+ levels 2.0 x ULN 14. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for = 3 years 15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form 16. Any known cardiac abnormalities such as: a. Patients with congenital long QT syndrome, b. Corrected QT interval > 480 msec (using the Fridericia formula), c. Myocardial infarction within 6 months of cycle 1 day 1, d. History of or concomitant significant cardiovascular disease, e. Ejection fraction <45% by MUGA scan or by echocardiogram. 17. Concomitant use of drugs that may cause a significant prolongation of the QTc. 18. Patients who have received more than 200 mg/m2 doxorubicin. 19. Concomitant use of strong CYP3A4 inhibitors (see Appendix) 20. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted. 21. Clinically significant active infection. 22. Use of any standard or experimental anti-cancer drug therapy wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) ;Secondary Objective: The secondary objectives are to compare Ro-CHOP and CHOP alone in terms of: • Overall survival • Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999) • Duration of response • Time to progression • Time to treatment failure • Safety • Quality of Life (QoL) • Response rates by PTCL histological subtypes • Response rate by standard prognostic parameters ;Primary end point(s): Progression-free survival (PFS) assessed according to progression criteria for malignant lymphoma 1999 by a Response adjudication committee.;Timepoint(s) of evaluation of this end point: Tumor assessment (clinical examination, laboratory tests, pelvis, abdominal, chest and cervical CT scan, bone marrow examination) will be performed at baseline, at mid-treatment after 3 cycles (CT scan only) and 4 weeks after the last treatment dose. To ensure comparability, baseline and on-study methods for response assessment will be performed using identical techniques. Follow-up assessment, including CT Scan, will be clinical visit every 3 months the first year, then every 4 months the 2nd year, and every 6 months thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival • Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999) • Duration of response • Time to progression • Time to treatment failure • Safety • Quality of Life (QoL) • Response rates by PTCL histological subtypes • Response rate by standard prognostic parameters ;Timepoint(s) of evaluation of this end point: • Overall survival: 2 years after the end of treatment • Overall Response Rate (ORR [PR+CR+CRu]): at the end of treatment • Duration of response: all duration of the study • Time to progression: all duration of the study • Time to treatment failure: all duration of the study • Safety: all duration of the study • Quality of Life (QoL) :At randomization, at D1 of cycle 4, at evaluation at the end of treatment, and during follow-up every 3 months the first year, every 4 months the second year and every year during follow-up period until primary analysis • Response rates by PTCL histological subtypes:at the end of treatment • Response rate by standard prognostic parameters: at the end of treatment | — |
Countries
Australia, Austria, Belgium, France, Germany, Italy, Korea, Democratic People's Republic of, Portugal, Spain
Contacts
Public ContactAnne Viola
LYSARC
Outcome results
None listed