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

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Kyowa Kirin

Status and phase

Active, not recruiting
Phase 2

Conditions

Indolent B-cell Non-Hodgkin's Lymphoma

Treatments

Drug: ME-401

Study type

Interventional

Funder types

Industry

Identifiers

NCT04533581
ME-401-K02

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

ME-401
Experimental group
Treatment:
Drug: ME-401

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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