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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

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ClinicalTrials.gov Identifier: NCT02564744
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Brief 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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma B-cell Non-Hodgkin's Lymphoma Drug: Debio 1562 Drug: Rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Debio 1562
Participants with a diagnosis of relapsed and/or refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), Follicular Non-Hodgkin's Lymphoma (FL), Marginal Zone/Mucosa-associated Lymphoid Tissue (MZ/MALT), Mantle Cell Lymphoma (MCL) or other Non-Hodgkin's Lymphoma (NHL) with the Sponsor's approval, will receive Debio 1562 and Rituximab in 3 different parts of study i.e., Safety run in, Part 2 and Expansion (Part 3). Participants in Part 2 will be enrolled in two parallel cohorts (Cohort A and Cohort B).
Drug: Debio 1562
Safety run in: Debio 1562 will be given on the same day as rituximab, once every three weeks (Q3W) intravenously (IV) at the dose of 0.7 mg/kg on Day 1 of a 21-day cycle. Part 2 and 3: Cohort A- Debio 1562 will be given on the same day as rituximab, once every three weeks (Q3W) intravenously (IV) at the dose of 0.7 mg/kg on Day 1 of a 21-day cycle. Cohort B- Debio 1562 will be given at a total dose of 0.8 milligram per kilogram (mg/kg) IV over a 21-day cycle.

Drug: Rituximab
Rituximab will be given on the same day as Debio 1562, Q3W IV at a dose of 375 mg/m^2 on Day 1 of a 21-day cycle.




Primary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 30 months ]
  2. Objective Response Rate (ORR) [ Time Frame: up to 30 months ]
    Number of participants with clinical responses as assessed by Lugano Classification of response assessments.


Secondary Outcome Measures :
  1. Maximum plasma drug concentration (Cmax) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  2. Area under the time-concentration curve from time 0 to t (AUC0-t) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  3. Area under the time-concentration curve from time 0 to infinity (AUC0-inf) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  4. Terminal half-life (t1/2) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  5. Clearance (CL) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  6. Volume of Distribution at Steady State (Vss) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  7. Time to Maximum Plasma Concentration (Tmax) of Debio 1562 and Rituximab [ Time Frame: Part 1: Pre-dose and within 5 minutes of infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2, 4-8; Part 2: Pre-dose and within 5 minutes of infusion, Day 1, 2, 3, 8, 15 for Cycles 1-2; Day 1, 8, 15 for Cycles 3-6 ]
  8. Progression-free survival (PFS) [ Time Frame: up to 30 months ]
  9. Time to response [ Time Frame: up to 30 months ]
  10. Duration of response (DOR) [ Time Frame: up to 30 months ]
  11. Overall survival (OS) [ Time Frame: up to 30 months ]
  12. Number of participants with presence of human anti-drug antibody (ADA) for Debio 1562 [ Time Frame: Pre-dose on Day 1 of Cycles 1 to 8; and at the end of treatment (Up to Month 36) and 30-day follow-up visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564744


Contacts
Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
United States, Alabama
Alabama Oncology Recruiting
Birmingham, Alabama, United States, 35211
United States, Connecticut
Smilow Cancer Center at Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Mcfarland Clinic PC Withdrawn
Ames, Iowa, United States, 50010
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Novant Health Oncology Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Spartanburg Regional Healthcare System Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Cancer Institute Withdrawn
Richmond, Virginia, United States, 23235
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98140
Belgium
CHU UCL Namur asbl - Site Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Jan Yperman Ziekenhuis Recruiting
Ieper, West-Vlaanderen, Belgium, 8900
Switzerland
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli Recruiting
Bellinzona, Ticino, Switzerland, 6500
Sponsors and Collaborators
Debiopharm International SA

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT02564744     History of Changes
Other Study ID Numbers: Debio 1562-201
2015-004061-87 ( EudraCT Number )
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents