Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease. (FIL_BVHD01)
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|ClinicalTrials.gov Identifier: NCT02227433|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : July 18, 2018
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL.
BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007).
Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.
• To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
- To assess duration of tumor control, including duration of response and progression-free survival
- To assess survival
- To assess the safety and tolerability of BV
• To assess disease-related symptoms Study Population Eligible patients are those with first relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, kidney, and liver function. Eligible patients must not previously have been treated with BV, patients must not have congestive heart failure, known cerebral/meningeal disease, or any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to first study dose.
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Brentuximab Vedotin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Brentuximab Vedotin (BV) in the Treatment of Elderly Hodgkin Lymphoma (HL) Patients at First Relapse or With Primary Refractory Disease.|
|Actual Study Start Date :||February 4, 2013|
|Actual Primary Completion Date :||April 3, 2018|
|Estimated Study Completion Date :||April 2019|
|Experimental: brentuximab vedotin (BV)||
Drug: Brentuximab Vedotin
Other Name: SGN
- Antitumor Efficacy [ Time Frame: two years ]• The antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
- Survival, safety and tolerability [ Time Frame: two years ]• The duration of tumor control, including duration of response and progression-free survival
- Survival [ Time Frame: Two years ]• The survival
- Safety and tolerability of Brentuximab Vedotin [ Time Frame: Two years ]• The safety and tolerability of BV
- Disease related symptoms [ Time Frame: Two years ]
• The disease-related symptoms
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): NCT02227433
|Irccs Centro Di Riferimento Oncologico Di Aviano (Pn)|
|Aviano, Italia, Italy, 33081|
|Policlinico S.Orsola Malpighi|
|Irccs Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli|
|Università La Sapienza|
|Rome, Italy, 00161|
|Principal Investigator:||Vittorio Stefoni||AO S. Orsola Malpighi|