Non Hodgkin Lymphoma Clinical Trial

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

Summary

This is an open label, multicenter, adaptive Phase 2 clinical study. The study will consist of a screening period, a treatment period, an end of treatment visit, and a follow-up period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT02564744

Recruitment Status:

Completed

Sponsor:

Debiopharm International SA

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There are 38 Locations for this study

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Alabama Oncology
Birmingham Alabama, 35211, United States
Carle Foundation Hospital, Cancer Center
Urbana Illinois, 61801, United States
Abbott Northwestern Hospital, Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Novant Health Oncology
Winston-Salem North Carolina, 27103, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Spartanburg Regional Healthcare System
Spartanburg South Carolina, 29303, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Swedish Medical Center
Seattle Washington, 98104, United States
CHU UCL Namur asbl - Site Godinne
Yvoir Namur, 5530, Belgium
Jan Yperman Ziekenhuis
Ieper West-Vlaanderen, 8900, Belgium
University Hospitals Leuven, Campus Gasthuisberg
Leuven , 3000, Belgium
St. Augustinus Hospital, Department of Hematology
Wilrijk , 2610, Belgium
University Multiprofile Hospital for Active Treatment "Sveti Georgi"
Plovdiv , 4002, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases,Clinic of Hematology
Sofia , 1756, Bulgaria
Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa
Vratsa , 3000, Bulgaria
University Hospital Brno
Brno , 625 0, Czechia
University Hospital Hradec Kralove
Hradec Králové , 500 0, Czechia
University Hospital Kralovske Vinohrady
Prague , 100 3, Czechia
General University Hospital in Prague
Prague , 128 0, Czechia
National Institute of Oncology
Budapest , H-112, Hungary
University of Debrecen Clinical Center
Debrecen , 4032, Hungary
Medical Center of the University of Pecs
Pécs , H-762, Hungary
University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona
Ancona , 60126, Italy
Civil Hospital of Brescia
Brescia , 25123, Italy
United Hospitals Villa Sofia Cervello
Palermo , 90146, Italy
Local Healthcare Company 8 Berica (Azienda ULSS8 Berica), Hospital San Bortolo of Vicenza
Vicenza , 36100, Italy
University Clinical Center in Gdansk
Gdańsk , 80-21, Poland
Provincial Hospitals in Gdynia Sp. z o.o. (LLC)
Gdynia , 81-51, Poland
Małopolskie Medical Centre
Kraków , 30-51, Poland
St. John of Dukla Oncology Center of Lublin Land
Lublin , 20-09, Poland
Regional Hospital of Bellinzona and Valli, Oncology Institute of Southern Switzerland
Bellinzona Ticino, 6500, Switzerland
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center
Cherkasy , 18009, Ukraine
Grigoriev Institute for Medical Radiology and Oncology of the National Academy of Medical Sciences of Ukraine
Kharkiv , 61024, Ukraine
Communal Non-profit enterprise "Regional Center of Oncology"
Kharkiv , 61070, Ukraine
National Institute of Cancer
Kyiv , 03022, Ukraine
National Research Center for Radiation Medicine
Kyiv , 03115, Ukraine
Kyiv City Clinical Hospital #9, City Hematology Center
Kyiv , 04112, Ukraine
Podillia Regional Oncology Center
Vinnytsia , 21029, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT02564744

Recruitment Status:

Completed

Sponsor:


Debiopharm International SA

How clear is this clinincal trial information?

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