Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 15, 2018
End Date:August 30, 2022
Contact:Precision for Medicine
Email:Triphase_TRPH-222-100_Inquiries@precisionformedicine.com
Phone:858-295-4326

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Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma

This is a Phase 1, multi-center, open-label study of TRPH-222 monotherapy in subjects with
relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages:
Dose-Escalation, Dose-Expansion.


Inclusion Criteria

- Age ≥ 18 years at the time of signing the informed consent

- Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL,
FL (including transformed FL), MZL, or MCL

- Relapsed and/or refractory NHL requiring systemic therapy and have failed, are
intolerant to, or are considered ineligible for standard of care anticancer treatments
that are known to be potentially curative. Subjects must not be current candidates for
HSCT. Participants who refuse standard treatments may also be considered provided that
documentation is provided that the subject has been made aware of all therapeutic
options

- Eastern Cooperative Oncology Group (ECOG) status 0-2

Exclusion Criteria

- Presence of a leukemic phase of the lymphoma

- "Double hit" or "triple hit" germinal center B cell lymphoma

- Previous solid organ allograft (except for corneal transplant)

- Peripheral neuropathy > NCI-CTCAE Grade 1

- Significant organ dysfunction that would preclude study participation

- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias

- Any other serious active disease or co-morbid medical condition, according to the
Investigator's decision or Medical Monitor, that will substantially increase the risk
associated with the subject's participation in the study
We found this trial at
5
sites
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Daniel J. Landsburg, MD
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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665 Elm Street
Buffalo, New York 14263
Principal Investigator: Francisco J. Hernandez-Ilizaliturri, MD
Phone: 716-845-4359
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Columbus, Ohio 43210
Principal Investigator: Beth Christian, MD
Phone: 614-366-0855
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Columbus, OH
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
Phone: 615-339-4214
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Nashville, TN
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Toronto, Ontario
Principal Investigator: John Kuruvilla, MD, FRCPC
Phone: 416-946-4501
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Toronto,
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