A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) (BV mini CHP)
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|ClinicalTrials.gov Identifier: NCT02734771|
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma||Drug: Brentuximab vedotin Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Elderly Patients With DLBCL|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2020|
Brentuximab vedotin 1.8 mg/kg IV day 1 for six cycles Rituximab 375 mg/m2 IV day 1 for six cycles Cyclophosphamide 400 mg/m2 IV day 1for six cycles Doxorubicin 25 mg/m2 IV day 1 for six cycles Prednisone 40 mg/m1 PO days 1-5 for six cycles
Drug: Brentuximab vedotin
Other Names:Drug: Rituximab
Other Names:Drug: Cyclophosphamide
Other Names:Drug: Doxorubicin
Other Names:Drug: Prednisone
- Percent of Subjects Completing Regimen [ Time Frame: 20 weeks ]Number of subjects who complete all 6 cycles of the therapy divided by the total number of subjects.
- Overall Survival [ Time Frame: 2 years ]Number of participants who are alive after two years.
- Progression Free Survival [ Time Frame: 2 years ]Per the Lugano Criteria, progression is defined as an individual node/lesion that increases in size by 50% or in the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (eg, a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline or any new or recurrent splenomegaly or new or clear progression of preexisting non-measured lesions or regrowth of previously resolved lesions. or assessable disease of any size unequivocally attributable to lymphoma or new or recurrent involvement.
- Overall Response Rate [ Time Frame: 20 weeks ]The overall response rate is the proportion of subjects who achieve a complete response or partial response based on the Lugano Criteria. Per the Lugano Criteria, complete response is defined as a Deauville score of 1, 2 or 3 and partial response is defined as Deauville score of 4 or 5, but decreased from baseline. Using CT measurements a complete response is defined as decrease in lymph node size to 1.5 cm, while a partial response is a 50% or greater reduction in size in 6 target lesions.
- Complete Response Rate [ Time Frame: 20 weeks ]Proportion of participants who have a complete response rate. Per the Lugano Criteria, complete response is defined as a Deauville score of 1, 2 or 3 and partial response is defined as Deauville score of 4 or 5, but decreased from baseline. Using CT measurements a complete response is defined as decrease in lymph node size to 1.5 cm, while a partial response is a 50% or greater reduction in size in 6 target lesions.
- Number of participants with impairment in physical function [ Time Frame: 20 weeks ]Activities of daily living (ADL): ADLs are measures of self-care. ADL independence will be assessed using the Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL. The Katz ADL is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates impairment.
- mean number of falls per participant [ Time Frame: 20 weeks ]
- Mean change in objective physical performance [ Time Frame: baseline and 20 weeks ]Physical performance will be tested using the short physical performance battery (range 0-12). Impairment is a score of less than or equal to 9.
- Mean number of comorbidities [ Time Frame: 20 weeks ]
- mean change in mini nutritional assessment [ Time Frame: baseline and 20 weeks ]The current MNA® is a 6 question assessment that identifies older adults who are malnourished or at risk of malnutrition. Scale=0-30. A score of less than or equal to 11 indicates impairment.
- Number of participants with any documented change in the Older Americans Resources and Services social resources assessment. [ Time Frame: baseline and 20 weeks ]This is a descriptive assessment.
- mean change in the geriatric depression screen [ Time Frame: baseline and 20 weeks ]The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. Scale ranges from 0-15 with a score of greater than or equal to 5 signifying impairment.
- mean change in cognition score [ Time Frame: baseline and 20 weeks ]Cognition will be assessed using the blessed orientation memory-concentration (BOMC) test. The BOMC is a screening tool allowing family members, caregivers, or health care professionals to check for suspected dementia in an elderly. Dementia is described as the progressive loss of memory and at least of one other cognitive area, such as language or behavior. The scale is -20 with a score of greater than 10 signifying impairment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734771
|Contact: Patrick M Reagan, MD||585-273-3258||Patrick_Reagan@urmc.rochester.edu|
|Contact: Yelena Lerman, PhD||585-276-8333||YLerman@urmc.rochester.edu|
|United States, New York|
|James P. Wilmot Cancer Institute, University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Patrick M Reagan, MD 585-273-3258 Patrick_Reagan@urmc.rochester.edu|
|Contact: Yelena Lerman, PhD 585-275-8333 YLerman@urmc.rochester.edu|
|United States, Virginia|
|University of Virginia Cancer Center||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Amelia Hodson, BSN, RN 434-297-4182 ASC5Y@virginia.edu|
|Principal Investigator:||Patrick M Reagan, MD||Wilmot Cancer Institute, University of Rochester Medical Center|