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Protein Kinase Inhibitor

R-CHOP + enzastaurin hydrochloride for Non-Hodgkin's Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Denovo Biopharma LLC
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 3.5 years
Awards & highlights

Study Summary

This trial is testing a new drug for people with a certain kind of blood cancer who have not yet been treated. The study will enroll 235 people who will be randomly assigned to receive either the new drug or a placebo. The study will last for up to 6 cycles of treatment.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 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
Overall survival in subjects who possess the DGM1™ biomarker
Secondary outcome measures
Overall survival in subjects who do not possess the DGM1™ biomarker
Safety of enzastaurin by assessing incidence of adverse events/serious adverse events, change of vital signs, ECG results, lab results, and physical exam findings from baseline
Other outcome measures
Presence of chromaturia as a predictor of efficacy

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: R-CHOP + enzastaurin hydrochlorideActive Control1 Intervention
Subjects in the R-CHOP + enzastaurin Arm will receive R-CHOP (Rituximab-375 mg/m2 i.v., Cyclophosphamide-750 mg/m2 i.v., Doxorubicin-50 mg/m2 i.v., Vincristine-1.4 mg/m2 i.v. (2 mg max), and Prednisone-100 mg p.o.), as directed, plus a 1125 mg loading dose of enzastaurin on Day 2 followed by 500 mg daily.
Group II: R-CHOP + placeboPlacebo Group1 Intervention
Subjects in the R-CHOP + placebo Arm will receive R-CHOP (Rituximab-375 mg/m2 i.v., Cyclophosphamide-750 mg/m2 i.v., Doxorubicin-50 mg/m2 i.v., Vincristine-1.4 mg/m2 i.v. (2 mg max), and Prednisone-100 mg p.o.), as directed, plus an identical number of tablets as the subjects in the enzastaurin Arm.

Find a Location

Who is running the clinical trial?

Denovo Biopharma LLCLead Sponsor

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
Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™
2018. "Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03263026.
~36 spots leftby Apr 2025
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