100 Participants Needed

DS-3201b for Lymphoma

Recruiting at 20 trial locations
(J
(U
Overseen By(For US sites) Daiichi Sankyo Contact for Clinical Trial Information
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Daiichi Sankyo Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research highlights the development of new drugs targeting specific pathways important for lymphoma growth, such as histone deacetylases, which are similar to the mechanism of action of DS-3201b. This suggests potential effectiveness in treating lymphomas by targeting these pathways.12345

What makes the drug DS-3201b unique for treating lymphoma?

The drug DS-3201b is unique for treating lymphoma because it is a novel targeted therapy, which means it specifically targets certain pathways in cancer cells to stop their growth, unlike traditional chemotherapy that affects both healthy and cancerous cells.12678

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

GC

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

If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a protocol-defined form of contraception or avoid intercourse, during and upon completion of the study, and for at least 3 months after the last dose of study drug
I am fully active or can carry out light work.
I am willing to provide tissue samples from my tumor for testing.
See 11 more

Exclusion Criteria

I have been diagnosed with a specific type of skin or blood cancer.
I have taken certain medications that affect liver enzymes or heart medication in the last 14 days.
I do not have any serious health or mental conditions that could worsen by joining this study.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4 weeks
Cycle 1 Day 1, Cycle 1 Day 15

Dose Expansion

Examine the safety and efficacy of DS-3201b for rare types of NHL and collect additional safety data.

4 weeks

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.

4 weeks
Day -4, Cycle 1 Day 1, Cycle 1 Day 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

  • DS-3201b
Trial Overview DS-3201b is an experimental drug being tested in adults with advanced non-Hodgkin lymphoma. The study has three parts: finding a safe dose (Dose Escalation), assessing effectiveness for rare NHL types and collecting safety data (Dose Expansion), and studying how DS-3201b affects the body's handling of other drugs when taken together (DDI Cohort - US only).
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dose Expansion - DS-3201bExperimental Treatment1 Intervention
Part 2 is a dose expansion to examine the safety and efficacy of DS-3201b.
Group II: Dose Escalation - DS-3201bExperimental Treatment1 Intervention
Dose escalation is to identify the recommended phase 2 dose of DS-3201b guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daiichi Sankyo Co., Ltd.

Lead Sponsor

Trials
116
Recruited
49,200+

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Industry Sponsor

Trials
390
Recruited
442,000+
Yuki Abe profile image

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Findings from Research

The introduction of rituximab has diminished the effectiveness of the International Prognostic Index (IPI) in predicting outcomes for patients with diffuse large B-cell lymphoma (DLBCL), as shown in a retrospective analysis of 831 patients.
The study validated the absolute lymphocyte count/revised International Prognostic Index (ALC/R-IPI) model, indicating it can still be useful for clinical trials, but highlights the need for a new prognostic model that better identifies high-risk patients in the context of modern treatments.
Prognostic models for diffuse large B-cell lymphoma in the rituximab era: a never-ending story.Bari, A., Marcheselli, L., Sacchi, S., et al.[2020]

References

Emerging synthetic drugs for the treatment of diffuse large B-cell lymphoma. [2023]
DLBCL: Who is high risk and how should treatment be optimized? [2023]
Summary and future directions. [2018]
Prognostic models for diffuse large B-cell lymphoma in the rituximab era: a never-ending story. [2020]
New drugs for aggressive B-cell and T-cell lymphomas. [2014]
Evaluation of treatment patterns and survival among patients with diffuse large B-cell lymphoma in the USA. [2019]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Nine-year experience in the treatment of patients with diffuse large B-cell lymphosarcoma]. [2011]
Lenalidomide in combination with R-CHOP produces high response rates and progression-free survival in new, untreated diffuse large B-cell lymphoma transformed from follicular lymphoma: results from the Phase 2 MC078E study. [2022]
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