TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Official Title

Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy

Summary:

The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.

Trial Description

Primary Outcome:

  • ORR as Assessed by IRC Based on Modified 2007 International Working Group (IWG) Criteria (Stage 2)
Secondary Outcome:
  • CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria (Stage 2)
  • ORR as Assessed by IRC Based on 2014 IWG-Lugano Criteria (Stage 2)
  • CR Rate as Assessed by IRC Based on 2014 IWG-Lugano Criteria (Stage 2)
  • Duration of Response (DOR) (Stage 2)
  • Duration of CR (Stage 2)
  • ORR as Assessed by IRC in Participants with Germinal Centre B-cell (GCB) DLBCL (Stage 2)
  • ORR as Assessed by IRC in Participants with DLBCL Transformed from Indolent non-Hodgkin Lymphoma (NHL) (Stage 2)
  • Progression Free Survival (PFS) as Assessed by IRC (Stage 2)
  • Overall Survival (OS) (Stage 2)
  • ORR as Assessed by IRC to Select the Dose Regimen of TAK-659 from the Lead-in Dose Exploration Phase (Stage 2)
  • ORR as Assessed by IRC at 3, 6, and 9 cycles in Participants with DLBCL (Stage 2)
The drug being tested is TAK-659. This study will look at the OR in participants with relapsed or refractory DLBCL who take TAK-659. The study will enroll approximately 122 participants. Participants will be assigned to: • TAK-659 60 mg to 100 mg All participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study in 28-day cycle. This multi-centre trial will be conducted in United States, United Kingdom, Spain, Italy, France, Canada, Germany. The overall time to participate in this study is approximately 48 months. Participants will be assessed for disease response and progression during the PFS follow-up of every 3 months after end of treatment (for participants who discontinue due to reasons other than disease progression) and OS follow-up of every 3 months from the last dose of study drug until death or conclusion of the study, whichever occurs first.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society