A Phase II Trial of PET-Directed Therapy using AVD (doxorubicin, vinblastine, and dacarbazine) plus Brentuximab Vedotin Induction Chemotherapy, with or without Brentuximab Vedotin plus Nivolumab, Followed by Nivolumab Consolidation for Patients with Previously Untreated Non-bulky Limited Stage Hodgkin Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: II
Principal Investigator: Kallam, Avyakta
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03233347#eligibility
Summary
PRIMARY OBJECTIVES:
I. To estimate progression-free survival (PFS) at 3 years in patients with previously untreated stage I or II non-bulky Hodgkin lymphoma (HL) who received doxorubicin hydrochloride, vinblastine, dacarbazine (AVD) plus brentuximab vedotin (BV) induction therapy followed by nivolumab (N)VB consolidation therapy.
SECONDARY OBJECTIVES:
I. To estimate the overall survival (OS) rate at 3 years in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.
II. To estimate the percentage of patients with untreated stage I or II non-bulky HL who are positron emission tomography (PET) positive versus PET negative after 3 cycles of AVD plus BV induction therapy.
III. To estimate PFS and OS at 3 and 5 years separately for patients who are PET negative versus PET positive after 3 cycles of AVD plus BV induction followed by NVB consolidation therapy.
IV. To estimate time to progression (TTP) in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.
V. To estimate the overall response rate and the number of patients who convert to complete response (CMR) after NVB in patients with partial response (PMR) at the end of AVD plus BV induction therapy.
VI. To evaluate the toxicity and tolerability of AVD plus BV induction followed by NVB consolidation therapy as assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v]4).