DS-3201b for Lymphoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but if you are part of the Drug-Drug Interaction (DDI) Cohort, you must not have taken certain medications like CYP3A inhibitors/inducers, P-gp inhibitors, midazolam, or digoxin within 14 days before starting the study.
What data supports the effectiveness of the drug DS-3201b for treating lymphoma?
What makes the drug DS-3201b unique for treating lymphoma?
What is the purpose of this trial?
DS-3201b is an experimental drug that is being investigated in clinical research.Adults with non-Hodgkin lymphoma (NHL) may be able to join this study if their disease has come back after remission or is not responding to current treatmentThis study has three parts. The Dose Escalation part is designed is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate. The Dose Expansion phase will determine how effective DS-3201b is for rare types of NH and collect additional safety data. Last, the Drug-Drug Interaction (DDI) Cohort (US Only) will evaluate the effect of DS-3201b on the pharmacokinetics (PK) of midazolam and digoxin when co-administered to patients with NHL
Research Team
Global Clinical Leader, MD
Principal Investigator
Daiichi Sankyo
Eligibility Criteria
Adults with non-Hodgkin lymphoma whose disease has returned after remission or isn't responding to treatment may join. They must be of legal age, have good performance status (able to carry out daily activities), agree to use contraception, and provide tumor tissue samples. People with certain types of T-cell lymphoma or leukemia, CNS involvement, recent stem cell transplant, other serious diseases, pregnancy or breastfeeding are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Identify the recommended phase 2 dose of DS-3201b guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation.
Dose Expansion
Examine the safety and efficacy of DS-3201b for rare types of NHL and collect additional safety data.
Drug-Drug Interaction (DDI) Cohort
Evaluate the effect of DS-3201b on the pharmacokinetics of midazolam and digoxin when co-administered to patients with NHL.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DS-3201b
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo Co., Ltd.
Lead Sponsor
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Daiichi Sankyo, Inc.
Industry Sponsor
Yuki Abe
Daiichi Sankyo, Inc.
Chief Medical Officer since 2022
MD
Hiroyuki Okuzawa
Daiichi Sankyo, Inc.
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University