Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL

Completed · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma, B-cell Non-Hodgkin's Lymphoma

In brief

The primary purpose of the study was to determine the safety and tolerability, anti-tumor activity of the proposed Debio 1562 dose regimens in combination with rituximab.

Key facts

Study ID

NCT02564744

Run by

Debiopharm International SA

People needed

100

Starts

2016-06-05

Expected to finish

2021-06-25

Last updated by the study team

2024-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Part 1 of the study, participants must have histopathologically confirmed diagnosis of R/R, DLBCL, FL, MZL/MALT, MCL, or other Sponsor approved NHL subtypes according to the World Health Organization (WHO) classification 2008 for which standard measures do not exist or are no longer effective.
• For Part 2 and Part 3 of the study, participants must have histopathologically and clinically confirmed diagnosis of relapsed DLBCL. Participants will be considered to have a relapsed disease if they showed a duration of response of at least 24 weeks after their first line of therapy. The following participants with relapsed DLBCL will be enrolled:
• Participants who received only one line of previous therapy and achieved either complete response (CR) or partial response (PR) for at least 24 weeks (from the last day of the last cycle) after their first line of therapy, but are not eligible for high dose chemotherapy with autologous stem cell transplantation (HD-ASCT)
• Participants who received more than one line of previous therapy (including HD-ASCT), and have achieved a duration of response (CR or PR) of at least 8 weeks (from the last day of the last cycle) after their last line of therapy
• Participants must have evaluable or measurable disease in accordance with the International Working Group Guidelines for Lymphoma.
• Participants must have received at least one but no more than six prior treatment regimens. Prior treatment with an anti-cluster of differentiation 20 (anti-CD20) agent, either alone or in combination, is allowed.
• Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
• Participants who are Hepatitis B surface antigen positive (HBsAg+) (must be polymerase chain reaction (PCR) negative) who are taking antivirals, are allowed to enroll.

You may not qualify if…

• Participants with a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• For Part 2 and Part 3 of the study, participants with primary refractory DLBCL (defined as progression of disease within 24 weeks after first line of treatment).
• For Part 2 and Part 3 of the study, participants that are eligible to undergo first time HD-ASCT.
• For Part 2 and Part 3 of the study, participants with R/R FL, MZL/MALT, MCL, or any other NHL subtypes according to the WHO classification.
• Participants with active hepatitis A, B or C infection.
• Women who are pregnant or breast feeding.
• Participants who have received prior therapy with other anti-CD37-targeting therapy.
• Participants who have known central nervous system, meningeal, or epidural disease including brain metastases.
• Participants with impaired cardiac function or clinically significant cardiac disease.
• Participants currently presenting interstitial lung disease, diffuse parenchymal lung disease, or with a past history of severe/Grade 3 parenchymal lung disorders.

Where it is running

• Alabama Oncology — Birmingham, Alabama, United States
• Carle Foundation Hospital, Cancer Center — Urbana, Illinois, United States
• Abbott Northwestern Hospital, Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
• Novant Health Oncology — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Spartanburg Regional Healthcare System — Spartanburg, South Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• CHU UCL Namur asbl - Site Godinne — Yvoir, Namur, Belgium
• Jan Yperman Ziekenhuis — Ieper, West-Vlaanderen, Belgium
• University Hospitals Leuven, Campus Gasthuisberg — Leuven, Belgium
• St. Augustinus Hospital, Department of Hematology — Wilrijk, Belgium
• University Multiprofile Hospital for Active Treatment "Sveti Georgi" — Plovdiv, Bulgaria
• Specialized Hospital for Active Treatment of Hematological Diseases,Clinic of Hematology — Sofia, Bulgaria
• Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa — Vratsa, Bulgaria
• University Hospital Brno — Brno, Czechia
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• University Hospital Kralovske Vinohrady — Prague, Czechia
• General University Hospital in Prague — Prague, Czechia
• National Institute of Oncology — Budapest, Hungary
• University of Debrecen Clinical Center — Debrecen, Hungary
• Medical Center of the University of Pecs — Pécs, Hungary
• University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona — Ancona, Italy
• Civil Hospital of Brescia — Brescia, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.