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Trial record 3 of 6 for:    ME-401

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

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ClinicalTrials.gov Identifier: NCT04533581
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Indolent B-cell Non-Hodgkin's Lymphoma Drug: ME-401 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: ME-401 Drug: ME-401
In the first 2 cycles (1 cycle is 28 days), subjects will be administered 60 mg of ME-401 orally once a day on a continuous schedule (CS). After that, subjects will be administered 60 mg of ME-401 orally once a day for the first 7 days, followed by rest for 21 days on an intermittent schedule (IS).




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]
    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 :
  1. Efficacy of ME-401 as assessed by the duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
  2. Efficacy of ME-401 as assessed by the progression-free survival (PFS) [ Time Frame: Up to approximately 4 years ]
  3. Efficacy of ME-401 as assessed by CR [ Time Frame: Up to approximately 4 years ]
  4. Efficacy of ME-401 as assessed by the Time to treatment failure (TTF) [ Time Frame: Up to approximately 4 years ]
  5. Efficacy of ME-401 as assessed by the objective response rate (ORR) [ Time Frame: Up to approximately 4 years ]
  6. Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 4 years ]
  7. 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 ]
  8. Plasma concentration level of ME-401 [ Time Frame: Up to approximately 4 years ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04533581


Contacts
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Contact: Kyowa Kirin Co., Ltd. +81-90-9975-7702 clinical.info.jp@kyowakirin.com

Locations
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Japan
Hokkaido University Hospital of the National University corporation Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT04533581    
Other Study ID Numbers: ME-401-K02
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases