CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Cyclophosphamide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03742258
NCT03742258Phase 1Completed

A Phase 1 Study of R-CHOP Plus SYK Inhibitor TAK-659 for the Front-Line Treatment of High-Risk Diffuse Large B Cell Lymphoma (DLBCL)

Northwestern University·interventional·Posted Nov 15, 2018·Updated Jun 18, 2025

In Brief

A Phase 1 clinical trial evaluating Cyclophosphamide, Doxorubicin Hydrochloride, and 4 other interventions for Diffuse Large B-Cell Lymphoma and 6 related conditions. Completed, enrolled 12 participants across 2 sites.

Detailed 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.

Study Details

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 15, 2018
Enrollment StartMar 13, 2019
Primary CompletionMar 12, 2021
Study CompletionFeb 8, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.6 years ago

Interventions

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Prednisonedrug

Given PO

Rituximabbiological

Given IV

Spleen Tyrosine Kinase Inhibitor TAK-659drug

Given PO

Vincristine Sulfatedrug

Given IV