This phase II trial studies how well brentuximab vedotin before autologous (taken from an individual's own cells) stem cell transplant works in treating patients with Hodgkin lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells.
PRIMARY OBJECTIVES: I. The primary objective of this study is to determine the activity of salvage brentuximab vedotin in Hodgkin lymphoma prior to autologous hematopoietic stem cell transplantation, as measured by overall response rate (ORR). SECONDARY OBJECTIVES: I. To describe the safety, toxicity, and tolerability of brentuximab vedotin as a salvage regimen. II. To summarize the stem cell mobilization results of patients receiving brentuximab vedotin as salvage therapy (e.g., total cluster of differentiation (CD)34+ cell yield, number of apheresis days, proportion of patients who achieve \>= 3 x 10\^6 CD34+ cells/kg). III. To evaluate potential changes in Hodgkin lymphoma biological markers of patients treated with brentuximab vedotin as first line salvage therapy. IV. To examine and characterize the outcomes of patients who receive brentuximab vedotin as first line salvage followed by autologous hematopoietic stem cell transplantation (AHCT) (e.g., toxicity, 2-year progression free survival \[PFS\], overall survival \[OS\], relapse-progression incidence and non-relapse mortality rate \[NRM\]) OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving complete remission (CR) after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses. After completion of study treatment, patients are followed up at 21 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Given IV
City of Hope Medical Center
Duarte, California, United States
Weill Medical College, Cornell University
New York, New York, United States
Overall Response Rate Among Patients With Salvage Brentuximab Vedotin (BV)
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Time frame: 21 days after completion of last course of study treatment, up to 5 years
Complete Response (CR) Rate Among Patients With Salvage Brentuximab Vedotin (BV)
The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.
Time frame: 21 days after completion of last course of study treatment, up to 5 years
Overall Response Rate in Cohort #2
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Time frame: 21 days after completion of last course of study treatment, up to 5 years
Complete Response (CR) Rate in Cohort #2
The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.
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Time frame: 21 days after completion of last course of study treatment, up to 5 years
Total CD34+ Cell Dose Among Patients Receiving Brentuximab Vedotin Followed by Autologous Hematopoietic Stem Cell Transplantation
Among the patients receiving salvage Brentuximab Vedotin (BV) followed by Autologous Hematopoietic Stem Cell Transplantation (AutoHCT), their total CD34+ cell yield by stem cell mobilization.
Time frame: 60 days after completion of last course of study treatment, up to conditioning regimens
Progression Free Survival at Year Two Among AutoHCT Patients With BV
Progression Free Survival (PFS) defined as the time from first treatment day (post AHCT) until objective or symptomatic relapse or death as a result of lymphoma or acute toxicity of treatment. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.
Time frame: Assessed for up to 5 years, at least half of the surviving participants followed 2+ years
Overall Survival at Year Two Among AutoHCT Patients With BV
Overall Survival (OS) defined as the time from first treatment day (post AHCT) until death. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.
Time frame: Assessed for up to 5 years, at least half of the surviving participants followed 2+ years