Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01796002|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2013
Last Update Posted : July 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: Romidepsin + CHOP Drug: CHOP||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||421 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 13, 2019|
|Estimated Study Completion Date :||December 13, 2022|
Experimental: Experimental: Romidepsin plus CHOP
Patients in experimental arm receive romidepsin plus CHOP (Ro-CHOP) administered in 3 week cycles for 6 cycles.
Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.
Drug: Romidepsin + CHOP
Ro-CHOP administered in 3 week cycles for 6 cycles or until progression Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.
Active Comparator: Standard: CHOP
Patients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.
- The primary efficacy endpoint is Progression Free Survival [ Time Frame: 60 months ]The primary efficacy endpoint is Progression Free Survival (PFS) using the response criteria for malignant lymphoma (1999) by a Response Adjudication Committee
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796002
|Study Chair:||Emmanuel BACHY, Professor||CH Lyon Sud, Pierre Bénite, France|
|Study Chair:||Vincent CAMUS, MD||Centre Henri Becquerel, Rouen, France|