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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01280526
Other study ID # Ro-CHOP
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 14, 2011
Last updated May 21, 2014
Start date January 2011
Est. completion date March 2014

Study information

Verified date May 2014
Source The Lymphoma Academic Research Organisation
Contact n/a
Is FDA regulated No
Health authority France: ANSM : Agence Nationale de sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

This study is an open label, multicenter study with two phases:

- A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.

- An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.


Description:

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 survival.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date March 2014
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 1. 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 ALK+ PTCL,

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 thereafter,

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 involved,

- 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 anemia,

- 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.

Study Design

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


Intervention

Drug:
Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma

Locations

Country Name City State
France Hôpital Henri Mondor Créteil
France CHU de Dijon Dijon
France Hôpital Claude Huriez Lille
France Centre Léon Bérard Lyon cedex 8
France Hôpital St Louis Paris
France Centre Hospitalier Lyon Sud Pierre-Bénite
France Centre Henri Becquerel Rouen
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
The Lymphoma Academic Research Organisation

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Dose Limiting Toxicities 42 days Yes
Secondary Complete Response Rate(CR) at the end of treatment 30 days after the end of treatment No
Secondary Progression-free survival (PFS) from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause No
Secondary Duration of Response from the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause No
Secondary Safety of association Romidepsin-CHOP Toxicities occured during the trial for all patient from the date of informed consent signature to 90 days after the last drug administration will be measured and reported for all grades toxicities according to CTCAE v4. from the date of informed consent signature to 90 days after the last drug administration Yes
Secondary Overall Response at the end of treatment 30 days after the end of treatment No
Secondary Overall Survival (OS) from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause No
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