Clinical Trials /

Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

NCT04533581

Description:

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.

Related Conditions:
  • Indolent Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04533581

Trial Eligibility

Document

Title

  • Brief Title: Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
  • Official Title: A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

Clinical Trial IDs

  • ORG STUDY ID: ME-401-K02
  • NCT ID: NCT04533581

Conditions

  • Indolent B-cell Non-Hodgkin's Lymphoma

Interventions

DrugSynonymsArms
ME-401ME-401

Purpose

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.

Trial Arms

NameTypeDescriptionInterventions
ME-401Experimental
  • ME-401

Eligibility Criteria

        Inclusion Criteria:

          -  Patients aged 20 years or older at the submission of the written informed consent form

          -  Patients that have undergone therapy after at least 2 prior systemic therapies
             (anti-CD20 Ab, chemo, and so on) for relapsed or refractory B-cell NHL

          -  Patients who have not undergone phosphatidylinositol 3-kinase (PI3K) inhibitors to
             date

          -  Patients who have not undergone Bruton's tyrosine kinase (BTK) inhibitors to date

          -  Patients with Eastern Cooperative Oncology Group Performance status (ECOG PS) "0 or 1"

        Exclusion Criteria:

          -  Patients with relapsed or refractory B-cell NHL who is categorized into Small
             lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), Lymphoplasmacytic
             lymphoma (LPL) by WHO classification

          -  Patients who have been histologically confirmed FL Grade 3b transformation from
             Follicular lymphoma (FL) to an aggressive lymphoma at least once

          -  Patients with lymphomatous involvement of the central nervous system

          -  Patients with uncontrolled clinically significant illness

          -  Patients with active interstitial lung disease or a history thereof
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:ORR is measured as the proportion of subjects achieving the best response rating of complete response (CR) or partial response (PR) prior to first progressive disease (PD).

Secondary Outcome Measures

Measure:Efficacy of ME-401 as assessed by the duration of response (DOR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Efficacy of ME-401 as assessed by the progression-free survival (PFS)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Efficacy of ME-401 as assessed by CR
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:
Measure:Plasma concentration level of ME-401
Time Frame:Up to approximately 4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kyowa Kirin Co., Ltd.

Last Updated

October 5, 2020