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A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP (Ro-CHOP) in the Treatment of Peripheral T-Cell Lymphomas

Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Peripheral T Cell Lymphoma

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Trial Information

A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP (Ro-CHOP) in the Treatment of Peripheral T-Cell Lymphomas

The primary objective of the study is to determine the feasibility of the combination and
the recommended dose (RD) of Romidepsin when administered in association with CHOP in a
population of patients with newly diagnosed Peripheral T-cell lymphoma (PTCL) as measured by
the toxicities during treatment.

Secondary objectives:

- To assess the safety of the association Romidepsin and CHOP,

- To assess the efficacy of the association of Romidepsin and CHOP: response rate and
complete response rate, progression-free survival, response duration and overall


Inclusion Criteria:

1. Patients with histologically confirmed Peripheral T-cell Lymphoma (PTCL), not
previously treated ; all subtypes may be included except HTLV-1-related T-cell
lymphoma, cutaneous T-cell lymphoma (mycosis fungoid and Sézary syndrome), and

2. Ann Arbor stages II - IV

3. Aged from 18 to 80 years,

4. ECOG performance status 0, 1 or 2,

5. Signed informed consent,

6. Negative pregnancy test for females of childbearing potential (FCBP),

7. FCBP using an effective method of birth control (i.e. hormonal contraceptive,
intrauterine device, diaphragm with spermicide, condom with spermicide or
abstinence) for the treatment period and for 1 month thereafter; Males using an
effective method of birth control for the treatment period and 3 months

8. Life expectancy of ≥ 90 days (3 months)

2. Exclusion Criteria:

1. Other types of lymphomas, e.g. B-cell lymphoma

2. Ann Arbor stage I

3. Previous treatment for PTCL with immunotherapy or chemotherapy except for
short-term corticosteroids before inclusion

4. Previous radiotherapy for PTCL except if localized to one lymph node area

5. Central nervous system - meningeal involvement

6. Contraindication to any drug contained in the chemotherapy regimen

7. HIV infection, active hepatitis B or C

8. Any serious active disease or co-morbid medical condition (according to
investigator's decision)

9. Any of the following laboratory abnormalities

- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),

- Platelet count < 100,000/mm3 (100 x 109/L), or 75,000 if bone marrow is

- Serum SGOT/AST or SGPT/ALT ≥ 5.0 x upper limit of normal (ULN),

- Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic

- Low K+ (inferior to low normal level) and low Mg+ (inferior to low normal
level)levels, except if corrected before beginning the chemotherapy,

10. Use of oral contraceptive and contraceptive patches,

11. Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min,

12. 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) unless the subject has been free of the disease for ≥ 3 years,

13. Any serious medical condition, laboratory abnormality, or psychiatric illness
that would prevent the subject from signing the informed consent form,

14. Left Ventricular Ejection Fraction < 45% (calculated by echocardiographic or
scintigraphic methods),

15. Patients with congenital long QT syndrome, history of significant cardiovascular
disease and/or taking drugs leading to significant QT prolongation,

16. Corrected QT interval > 480 msec (using the fridericia formula)

17. Use of any standard or experimental anti-cancer drug therapy within 28 days of
the initiation (Day 1) of study drug ,

18. Pregnant or lactating females or women of childbearing potential not will-ing to
use an adequate method of birth control for the duration of the study.

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of Dose Limiting Toxicities

Outcome Time Frame:

42 days

Safety Issue:


Principal Investigator

Bertrand COIFFIER, Professor

Investigator Role:

Principal Investigator


France: ANSM : Agence Nationale de sécurité du Médicament et des produits de santé

Study ID:




Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Peripheral T Cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral