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Small Molecule

DS-3201b for Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has relapsed from or is refractory to standard treatment or no standard treatment is available
Has preserved organ function based on baseline laboratory data at screening tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up witihn 5 years
Awards & highlights

Study Summary

This trial is currently enrolling in the US, South Korea, and Taiwan.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Specific side effects of DS-3201b aren't listed but could include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies. Participants will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve with standard treatment or there is no standard treatment available.
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My organ functions are normal according to my recent tests.
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I have been diagnosed with non-Hodgkin's lymphoma.
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I am willing to give a fresh tissue sample at the end of my treatment.
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I am willing to provide tissue samples from my tumor for testing.
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My ATL is acute, lymphomatous, or chronic with a poor outlook.
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My cancer came back or didn't respond after at least 1 treatment.
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I am fully active or can carry out light work.
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I am willing to provide tissue samples from my tumor for testing.
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My cancer came back or didn't respond after at least 1 treatment.
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I am legally an adult in my country.
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My ATL is acute, lymphomatous, or chronic with a poor outlook.
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My condition did not improve with standard treatment or there is no standard treatment available.
Select...
I have been diagnosed with non-Hodgkin's lymphoma.
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I am legally an adult in my country.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin
DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin
Digoxin
+9 more
Secondary outcome measures
Best overall response, based on international consensus criteria
Disease control rate (DCR)
Duration of response (DOR)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DS-3201bExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DS-3201b
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
388 Previous Clinical Trials
409,467 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
415,065 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
49,129 Total Patients Enrolled

Media Library

DS-3201b (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT02732275 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: DS-3201b
Non-Hodgkin's Lymphoma Clinical Trial 2023: DS-3201b Highlights & Side Effects. Trial Name: NCT02732275 — Phase 1
DS-3201b (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02732275 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its seal of approval to DS-3201b?

"Due to the lack of safety and efficacy data in Phase 1 trials, we assign a score of 1 out of 3 for DS-3201b's safety profile."

Answered by AI

How many geographical sites are actively conducting this research?

"This experiment is currently being conducted at 10 locations across the nation, including Atlanta, New york City and Columbus. It would behoove those interested in participating to select a nearby site so as to reduce travel demands."

Answered by AI

Have you opened recruitment for this trial yet?

"The analysis of clinicaltrials.gov states that this particular medical trial is no longer looking to recruit patients, having last been updated on August 30th 2022 after being initially posted on March 31st 2016. Notwithstanding, there are 1726 other studies actively searching for participants at the current time."

Answered by AI

What are the desired outcomes of this research endeavor?

"This clinical trial seeks to evaluate the Average plasma concentration (Cavg) over a 28-day cycle. Secondary endpoints include assessing responses from participants with CTCL and malignant lymphoma using 2011 CTCL criteria, international consensus standards, and objective response rate measures."

Answered by AI
~11 spots leftby Mar 2025