Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open label, multicenter study with two phases:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romidepsin dose 10mg/m² | Experimental | Romidepsin dose 10mg/m² |
|
| Romidepsin dose 12mg/m² | Experimental | Romidepsin dose 12mg/m² |
|
| Romidepsin dose 14mg/m² | Experimental | Romidepsin dose 14mg/m² |
|
| Romidepsin dose 8mg/m² | Experimental | Romidepsin dose 8mg/m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romidepsin and CHOP | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate(CR) at the end of treatment | 30 days after the end of treatment | |
| Progression-free survival (PFS) | from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other types of lymphomas, e.g. B-cell lymphoma
Ann Arbor stage I
Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids before inclusion
Previous radiotherapy for PTCL except if localized to one lymph node area
Central nervous system - meningeal involvement
Contraindication to any drug contained in the chemotherapy regimen
HIV infection, active hepatitis B or C
Any serious active disease or co-morbid medical condition (according to investigator's decision)
Any of the following laboratory abnormalities
Use of oral contraceptive and contraceptive patches,
Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min,
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,
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
Left Ventricular Ejection Fraction < 45% (calculated by echocardiographic or scintigraphic methods),
Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation,
Corrected QT interval > 480 msec (using the fridericia formula)
Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug ,
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bertrand COIFFIER, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | 94010 | France | |||
| CHU de Dijon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26687958 | Derived | Dupuis J, Morschhauser F, Ghesquieres H, Tilly H, Casasnovas O, Thieblemont C, Ribrag V, Bossard C, Le Bras F, Bachy E, Hivert B, Nicolas-Virelizier E, Jardin F, Bastie JN, Amorim S, Lazarovici J, Martin A, Coiffier B. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study. Lancet Haematol. 2015 Apr;2(4):e160-5. doi: 10.1016/S2352-3026(15)00023-X. Epub 2015 Mar 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Romidepsin and CHOP | Drug | 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 | Drug | 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 | Drug | 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 |
|
| 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 |
| 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 |
| Overall Response at the end of treatment | 30 days after the end of treatment |
| Overall Survival (OS) | from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause |
| Dijon |
| 21000 |
| France |
| Hôpital Claude Huriez | Lille | 59037 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Hôpital St Louis | Paris | 75475 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C087123 | romidepsin |
Not provided
Not provided
Not provided