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Chemotherapy Agent

Spleen Tyrosine Kinase Inhibitor TAK-659 for Diffuse Large B-Cell Lymphoma

Phase 1
Waitlist Available
Led By Reem Karmali
Research Sponsored by Northwestern University
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 from study enrollment until progression/recurrence of lymphoma or death from any cause, assessed up to 3 years
Awards & highlights

Study Summary

This study is evaluating a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL).

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma
  • Large B-Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until progression/recurrence of lymphoma or death from any cause, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment until progression/recurrence of lymphoma or death from any cause, assessed up to 3 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
Incidence and grade of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities
Secondary outcome measures
Overall response rate (ORR)
Progression free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (R-CHOP, TAK-659)Experimental Treatment6 Interventions
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in course 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Prednisone
FDA approved
Vincristine
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,219 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,260 Total Patients Enrolled
Reem KarmaliPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma
2019. "Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03742258.
All > Diffuse Large B Cell Lymphoma
~2 spots leftby Apr 2025
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