TAK-981 with rituximab for relapsed / refractory Non-Hodgkin Lymphoma
Research type
Research Study
Full title
Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma
IRAS ID
1003699
Contact name
Graham Collins
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2020-003946-36
Clinicaltrials.gov Identifier
Research summary
Research Summary
Non-Hodgkin lymphoma (NHL) is among the most common cancers in Europe. Chemotherapy is the main treatment for most NHL types and anti-tumour monoclonal antibodies also have an important role. However, once NHL becomes resistant to standard chemotherapy and antibody therapies, the overall prognosis is poor with limited long-term survival.
As of 28 June 2020, TAK-981 has been given to 31 participants in different research studies and overall has been well tolerated.
The purpose of this study is to assess the safety and efficacy of TAK-981 in combination with rituximab (a monoclonal antibody) in certain NHL types.
Phase 1 of the study is a dose escalation phase to determine a recommended dose of TAK-981. The UK will not participate in this phase. Phase 2 of the study will investigate TAK-981 in 3 cohorts for different NHL types. For each cohort, an analysis will be performed when a certain number of patients have been enrolled. If a minimal response rate is not achieved, that cohort will be closed. If a clear clinical benefit is observed, additional patients will be enrolled into that cohort.
The study will involve a 28-day screening period, a treatment period, an end of treatment visit 30 days after the last dose and a follow-up period for a maximum of one year. During the treatment period, participants will receive TAK-981 and rituximab in 21-day cycles for up to 12 months or until disease progression, unacceptable toxicity or another withdrawal criterion is met.
Participants will attend study visits at regular intervals for safety and efficacy assessments including assessment of side effects and other medications, physical examination, vital signs, blood and urine samples, ECG, CT or MRI and FDG-PET scans, ECHO or MUGA scans, and biopsy.
This study is sponsored by Takeda Development Center Americas, Inc.. Approximately 130 patients will participate in this study worldwide with 10 participants from 5 hospitals in the UK.
Summary of results
Lay summary of study results will be available on the company website, ie. https://clinicaltrials.takeda.com/study-detail/5f6b603c4db2bf003ab4a352?idFilter=["TAK-981-1501"]
REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0057
Date of REC Opinion
8 Jul 2021
REC opinion
Further Information Favourable Opinion