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NCT03742258 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT03742258: Completed Phase 1 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by Northwestern University.
NCT03742258 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified that has completed, run by Northwestern University. The registered enrollment target is 12 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03742258, a Phase 1 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
Primary Outcome
Determine the safety and establish the maximum tolerated dose of TAK-659 when combined with R-CHOP in the front-line treatment of high-risk DLBCL using only patients who are evaluable for dose limiting (DLT) toxicities. MTD for TAK-659 will be determined using a 3+3 dose escalation method. The starting dose was 60 mg with possible escalation to 80 mg and 100 mg. Patients may be de-escalated to 40 mg if DLT's were met at dose level 1.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Prednisone
- BIOLOGICAL Rituximab
- DRUG Spleen Tyrosine Kinase Inhibitor TAK-659
Study Locations (2)
Illinois
- Northwestern University - Chicago
- Northwestern Lake Forest Hospital - Lake Forest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2024-02-08 |
| Phase | Phase 1 |
What the finished NCT03742258 record still lists
NCT03742258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (95% lower).
The record links to 7 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03742258 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03742258 about?
NCT03742258 is a clinical study titled "Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma". The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administra...
What is the current status of trial NCT03742258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-03-13. Estimated completion is 2024-02-08.
What conditions does trial NCT03742258 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma.
What interventions are being tested in trial NCT03742258?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL), Spleen Tyrosine Kinase Inhibitor TAK-659 (DRUG).
Who is sponsoring clinical trial NCT03742258?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03742258 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03742258's enrollment target sits among peer trials
12 104th of 114 higher than 9 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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