Last updated on June 2017

Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)


Brief description of study

This study evaluates ADCT-402 in patients with Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL). Patients will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In Part 2, patients will receive the dose level identified in Part 1.

Detailed Study Description

Study ADCT-402-101 is the first clinical study with ADCT-402 in patients with B-cell non-Hodgkin Lymphoma (NHL). ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated via a valine-alanine cleavable, maleimide linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. The study will be conducted in 2 parts. In Part 1 (dose escalation) patients will receive an infusion of ADCT-402, at escalating doses. Part 1 will continue until the maximum tolerated dose is determined. In Part 2 (expansion), patients will be assigned to the recommended dose level and/or schedule of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee. For each patient, the study will include a screening period (up to 28 days), a treatment period (until withdrawal), and a follow-up period to assess disease progression and survival for up to 12 months after the last dose of study drug. The total study duration will be dependent on overall patient tolerability to the study drug and response to treatment. It is anticipated that the duration of the entire study (Parts 1 and 2) could be approximately 3 years from first patient treated to last patient completed.

Clinical Study Identifier: NCT02669017

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Erin Reid, MD

UC San Diego Moores Cancer Center
La Jolla, CA United States
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Leonard Heffner Jr., MD

Winship Cancer Institute of Emory University
Atlanta, GA United States
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Melham Solh, MD

Blood and Marrow Transplant Group of Georgia
Atlanta, GA United States
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Brad Kahl, MD

Washington University School of Medicine
Saint Louis, MO United States
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Owen O'Connor, M.D., PhD.

Columbia University Medical Center Herbert Irving Pavilion
New York, NY United States
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Paolo Caimi, MD

University Hospitals of Cleveland
Cleveland, OH United States
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Ki Y Chung, MD

Greenville Health System, Institute for Translational Oncology Research, Clinical Research Unit
Greenville, SC United States
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Mehdi Hamadani, MD

Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, WI United States
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Carmelo Carlo-Stella

U.O Oncologia e Ematologia - Istituto Clinico Humanitas
Milano, Italy
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Kirit Ardeshna

University College London Hospitals
London, United Kingdom
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John Radford

The Christie NHS Foundation Trust
Manchester, United Kingdom
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