A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)
Who is this study for? Patients with relapsed/refractory diffuse large B-cell lymphoma
What treatments are being studied? DPX-Survivac
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults ≥ 18 years of age who are willing and able to provide written informed consent
• Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.
• Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.
• Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).
• Subjects must have failed or be ineligible for ASCT or CAR-T
• Have at least one bi-dimensionally measurable lesion per Lugano (2014)
• Willing to provide pre-treatment and on-treatment tumor biopsy tissue.
• Meet protocol-specified laboratory requirements
• Life expectancy \> 3 months.
Locations
United States
California
Compassionate Cancer Care Medical Group
RECRUITING
Fountain Valley
Florida
Boca Raton Regional Hospital
WITHDRAWN
Boca Raton
BRCR Medical Center Inc.
WITHDRAWN
Hollywood
BRCR Medical Center Inc.
WITHDRAWN
Plantation
Comprehensive Hematology and Oncology
WITHDRAWN
St. Petersburg
Georgia
Blood and Marrow Transplant Group of Georgia
RECRUITING
Atlanta
Indiana
Indiana University Health Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Louisiana
Tulane Cancer Center Office of Clinical Research
RECRUITING
New Orleans
North Carolina
Brody School of Medicine at East Carolina University
RECRUITING
Greenville
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Mexico
Christus St. Vincent Regional Cancer Center
RECRUITING
Santa Fe
Ohio
Gabrail Cancer Center Research
WITHDRAWN
Canton
Toledo Clinic Cancer Center
RECRUITING
Toledo
University of Toledo Medical Center
WITHDRAWN
Toledo
Pennsylvania
Allegheny Health Network (AHN) West Penn Hospital
RECRUITING
Pittsburgh
Reading Hospital - McGlinn Cancer Institute
RECRUITING
West Reading
South Dakota
Prairie Lakes Health Care System
WITHDRAWN
Watertown
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Box Hill Hospital
RECRUITING
Melbourne
Epworth Freemasons Hospital
RECRUITING
Melbourne
Westmead Hospital
RECRUITING
Westmead
Canada
Saskatoon Cancer Center
RECRUITING
Saskatoon
France
Hôpital Avicenne
RECRUITING
Bobigny
Centre d'Oncologie de Gentilly
RECRUITING
Nancy
Hôpital Privé du Confluent
RECRUITING
Nantes
Centre Antoine Lacassagne
RECRUITING
Nice
Hôpital de la Pitié-Salpêtrière
RECRUITING
Paris
Hôpital Necker
RECRUITING
Paris
Hôpital Saint-Antoine
RECRUITING
Paris
Centre Hospitalier de Périgueux
RECRUITING
Périgueux
CHU Bordeaux- Hôpital Haut Lévêque
RECRUITING
Pessac
Centre Hospitalier de Saint-Quentin
RECRUITING
Saint-quentin
Hungary
Debreceni Egyetem Klinikai Központ
RECRUITING
Debrecen
SzSzBM Korhazak es Egyetemi Oktatokorhaz
RECRUITING
Nyíregyháza
New Zealand
North Shore Hospital
RECRUITING
Auckland
Palmerston North Hospital
RECRUITING
Palmerston North
Poland
Szpitale Pomorskie Sp. z o. o.
RECRUITING
Gdynia
Wojewódzki Szpital Specjalistyczny w Legnicy
RECRUITING
Legnica
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
RECRUITING
Olsztyn
Centrum Medyczne Pratia Poznań
RECRUITING
Skórzewo
Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie
RECRUITING
Warsaw
Romania
Bucharest Oncology Institute Prof.Dr.Al. Trestioreanu
RECRUITING
Bucharest
The Oncology Institute Prof. Dr. Ion Chiricuţă I.O.C.H.
RECRUITING
Cluj-napoca
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Oncology Institute of Vojvodina
RECRUITING
Kamenitz
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Clinical Hospital Center Zemun
RECRUITING
Zemun
Spain
Hospital Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Time Frame
Start Date:2021-06-18
Estimated Completion Date:2025-04
Participants
Target number of participants:102
Treatments
Experimental: Arm 1: DPX-Survivac, pembrolizumab, CPA
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. CPA will be self-administered 50 mg BID for 7 days on and 7 days off starting on D0.
Experimental: Arm 2: DPX-Survivac, pembrolizumab
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. Subjects randomized to Arm 2 will not receive CPA.