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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

This study is currently recruiting participants.
Verified November 2017 by Debiopharm International SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT02564744
First Posted: October 1, 2015
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Debiopharm International SA
  Purpose
This is an open label, multicenter, non-randomized phase 2 (with safety run-in phase) clinical study. The study will consist of a screening period, a treatment period, an end of treatment visit, and a follow-up period.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 20 months ]
  • Objective Response Rate (ORR) [ Time Frame: up to 20 months ]
    Number of participants with clinical responses as assessed by Lugano Classification of response assessments.


Secondary Outcome Measures:
  • Maximum plasma drug concentration (Cmax) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Area under the time-concentration curve from time 0 to t (AUC0-t) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Area under the time-concentration curve from time 0 to infinity (AUC0-inf) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Terminal half-life (t1/2) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Clearance (CL) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Volume of Distribution at Steady State (Vss) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Time to Maximum Plasma Concentration (Tmax) of Debio 1562 and Rituximab [ Time Frame: Pre-dose and within 5 minutes of drug infusion, on Day 1, 2, 3, 8, 15 for Cycles 1 and 3; and on Day 1 for Cycles 2 and 4 through 8 ]
  • Progression-free survival (PFS) [ Time Frame: up to 20 months ]
  • Time to response [ Time Frame: up to 20 months ]
  • Duration of response (DOR) [ Time Frame: up to 20 months ]
  • Overall survival (OS) [ Time Frame: up to 20 months ]
  • 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 ]

Estimated Enrollment: 75
Actual Study Start Date: May 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety run-in
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.
Drug: Debio 1562
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.
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.
Experimental: Phase 2- Cohort 1
Participants with a diagnosis of R/R DLBCL (de novo or transformed) will receive Debio 1562 and Rituximab.
Drug: Debio 1562
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.
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.
Experimental: Phase 2- Cohort 2
Participants with a diagnosis of R/R FL, MZ/MALT, or other subtypes of NHL will receive Debio 1562 and Rituximab.
Drug: Debio 1562
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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Pathologically confirmed R/R DLBCL, FL, marginal zone lymphoma (MZL)/MALT, MCL, or other Sponsor approved NHL subtypes.
  • 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.

Exclusion Criteria:

  • Participants with a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Participants with active hepatitis A, B or C infection or other uncontrolled intercurrent illness.
  • Women who are pregnant or breast feeding.
  • Participants who have received prior therapy with other anti-CD37-targeting antibody drug conjugate.
  • Participants who have known central nervous system, meningeal, or epidural disease including brain metastases.
  • Participants with impaired cardiac function or clinically significant cardiac disease.
  Contacts and Locations
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: Mahdi Farhan, MD +41 21 321 01 11

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 Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Mcfarland Clinic PC Recruiting
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
  More Information

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 Submitted: September 11, 2015
First Posted: October 1, 2015
Last Update Posted: November 24, 2017
Last Verified: November 2017
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