Clinical Trials /

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

NCT02564744

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: Debio 1562-201
  • SECONDARY ID: 2015-004061-87
  • NCT ID: NCT02564744

Conditions

  • Diffuse Large B-Cell Lymphoma
  • B-cell Non-Hodgkin's Lymphoma

Interventions

DrugSynonymsArms
Debio 1562Safety run-in
RituximabSafety run-in

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.

Trial Arms

NameTypeDescriptionInterventions
Safety run-inExperimentalParticipants 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.
  • Debio 1562
  • Rituximab
Phase 2- Cohort 1ExperimentalParticipants with a diagnosis of R/R DLBCL (de novo or transformed) will receive Debio 1562 and Rituximab.
  • Debio 1562
  • Rituximab
Phase 2- Cohort 2ExperimentalParticipants with a diagnosis of R/R FL, MZ/MALT, or other subtypes of NHL will receive Debio 1562 and Rituximab.
  • Debio 1562
  • Rituximab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame:up to 20 months
Safety Issue:
Description:Number of participants with clinical responses as assessed by Lugano Classification of response assessments.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:up to 20 months
Safety Issue:
Description:
Measure:Time to response
Time Frame:up to 20 months
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:up to 20 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:up to 20 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Debiopharm International SA

Last Updated

August 31, 2017