Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02275598|
Recruitment Status : Unknown
Verified October 2014 by Massimo Federico, MD, University of Modena and Reggio Emilia.
Recruitment status was: Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Brentuximab vedotin Drug: ABVD||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Study To Assess The Efficacy Of Brentuximab Vedotin Administered Sequentially With ABVD Chemotherapy In Patients With Untreated Hodgkin Lymphoma.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||March 2015|
Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
Drug: Brentuximab vedotin
1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2
Other Name: Adcetris
Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle. Number of Cycles: 3 or 6 according to initial disease stage.
- Number of Participants with Complete Metabolic Response by FDG-PET [ Time Frame: between day +8 and day +15 from second administration of Brentuximab ]Complete Metabolic Response will be defined by Deauville score 1, 2, 3.
- Overall Response Rate (ORR) [ Time Frame: Up to 4 weeks from the end of full treatment program. ]
- Progression Free Survival (PFS) [ Time Frame: at 1 year from the end of full treatment program. ]
- Number of Participants with Adverse Events [ Time Frame: from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program. ]All serious and on-serious adverse events will be assessed
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): NCT02275598
|Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna|
|Bologna, Italy, 40138|
|Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia|
|Modena, Italy, 41124|
|Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS|
|Reggio Emilia, Italy, 42100|
|Study Chair:||Massimo Federico, MD||Department of Diagnostic, Clinical and Public Health Medicine|