PHASE 3 MULTI-CENTER RANDOMIZED STUDY TO COMPARE EFFICACY AND SAFETY OF ROMIDEPSIN CHOP (Ro-CHOP) VERSUS CHOP IN PATIENTS WITH PREVIOUSLY UNTREATED PERIPHERAL T-CELL LYMPHOMA
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 (I - IV):
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+ aggressive
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
8. Life expectancy of ≥ 90 days (3 months).
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:
1. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
2. Extranodal T-cell/NK-cell lymphoma, nasal type
3. Anaplastic large cell lymphoma, ALK-positive type
4. Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)
5. Primary cutaneous CD30+ T-cell lymphoproliferative disorder
6. Primary cutaneous anaplastic T-cell lymphoma
5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term
corticosteroids (duration of ≤ 8 days) before randomization
6. Previous radiotherapy for PTCL except if localized to one lymph node area
7. Patients planned for autologous or allogeneic transplant as consolidation in first
8. Central nervous system -meningeal involvement
9. Contraindication to any drug contained in the chemotherapy regimen,
10. Subjects with HIV positivity
11. Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without HBV
DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal
transaminases) are eligible.
12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:
1. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
2. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is
3. Serum SGOT/AST or SGPT/ALT ≥ 3.0 x upper limit of normal (ULN),
4. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
5. K+ and Mg2+ levels < LLN, except if corrected per protocol guidance before
beginning the romidepsin infusion
13. Serum creatinine > 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:
1. Patients with congenital long QT syndrome
2. Corrected QT interval > 480 msec (using the Fridericia formula)
3. Myocardial infarction within 6 months of cycle 1 day 1
4. History of or concomitant significant cardiovascular disease
5. 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
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 within 28 days of the
initiation (Day 1) of study drug
23. Pregnant or lactating females or women of childbearing potential not willing to use
an adequate method of birth control for the duration of the study.