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



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:May 2016
End Date:April 1, 2022
Contact:Debiopharm International S.A
Email:clinicaltrials@debiopharm.com
Phone:+41 21 321 01 11

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A Phase 2 Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma and Other Forms of Non-Hodgkin's Lymphoma

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.


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:

1. Participants who received at least 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)

2. 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-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 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, patients 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.
We found this trial at
18
sites
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Birmingham, Alabama 35223
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Dallas, Texas 75246
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2615 East Clinton Avenue
Fresno, California 93703
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Greenville, South Carolina 29607
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Louisville, Kentucky 40207
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Minneapolis, Minnesota 55408
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Richmond, Virginia 23235
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Spartanburg, South Carolina 29303
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3333 Silas Creek Parkway
Winston-Salem, North Carolina 27103
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1 Rue Docteur Gaston Therasse
Yvoir, Namur 5530
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Yvoir,
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