Your session is about to expire
← Back to Search
Monoclonal Antibodies
TAK-981 for Non-Hodgkin's Lymphoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights
Study Summary
This trial is testing TAK-981, given with rituximab, to see if it is safe and works well in adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma.
Eligible Conditions
- Non-Hodgkin Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Duration of TEAEs
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) per Dose Level
Phase 1: Number of Participants With Grade 3 or Higher TEAEs
+2 moreSecondary outcome measures
AUC0-t: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981
AUC0-∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981
CL: Total Clearance After Intravenous Administration for TAK-981
+10 moreSide effects data
From 2014 Phase 3 trial • 519 Patients • NCT0133299415%
Nasopharyngitis
6%
Hypertension
1%
Bursitis
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ/TCZ or TCZ/RTX
Trial Design
10Treatment groups
Experimental Treatment
Group I: Phase 2 (C): TAK-981 120 mgExperimental Treatment2 Interventions
Participants with follicular lymphoma (FL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group II: Phase 2 (A): TAK-981 120 mgExperimental Treatment2 Interventions
Participants with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group III: Phase 1: TAK-981 90mg QWExperimental Treatment2 Interventions
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group IV: Phase 1: TAK-981 90mg BIWExperimental Treatment2 Interventions
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group V: Phase 1: TAK-981 60mg QWExperimental Treatment2 Interventions
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group VI: Phase 1: TAK-981 40mg QWExperimental Treatment2 Interventions
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group VII: Phase 1: TAK-981 120mg QWExperimental Treatment2 Interventions
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group VIII: Phase 1: TAK-981 10mg QWExperimental Treatment2 Interventions
Participants with indolent or aggressive non-Hodgkin lymphoma (NHL) received TAK-981 10 mg, infusion, intravenously (IV), once weekly (QW) on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 milligram per square meter (mg/m^2), infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or disease progression (PD) or unacceptable toxicity.
Group IX: Phase 1: Japan Lead-in: TAK-981 60mg QWExperimental Treatment2 Interventions
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
Group X: Phase 1: Japan Lead-in: TAK-981 60mg BIWExperimental Treatment1 Intervention
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-981
2020
Completed Early Phase 1
~20
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,223 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,208 Previous Clinical Trials
489,656 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What applications is TAK-981 commonly used for?
"TAK-981 is widely used to address diffuse large b-cell lymphoma (dlbcl), but has been proven effective for treating other conditions such as certain forms of lymphomas, polyangium, and pemphigus vulgaris."
Answered by AI
Could you provide an overview of all the experiments concerning TAK-981?
"Initially researched in 1993 at National Institutes of Health Clinical Center, TAK-981 has since seen 805 completed studies. There are currently 409 active trials located primarily around Tyler, Texas."
Answered by AI
Are there numerous medical facilities in this city testing the efficacy of this study?
"A total of 15 clinical trial sites are currently operating, such as Texas Oncology (Tyler) - USOR in Tyler, Centre Hospitalier de l'Universite de Montreal in Montreal and University Hospitals Cleveland Medical Center in Cleveland. Furthermore, there are a dozen other locales that are participating."
Answered by AI
Are there available slots for participants in this experiment?
"This medical research has been accepting applicants since October 15th of 2019, as evidenced by clinicaltrials.gov's records. The trial was last modified on August 16th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger