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PI3K inhibitor

Tenalisib for Peripheral T-Cell Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Rhizen Pharmaceuticals SA
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 years
Awards & highlights

Study Summary

This trial will study the effects of two doses of the drug tenalisib when given with the standard CHOP regimen to patients with newly diagnosed PTCL.

Eligible Conditions
  • Peripheral T-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Complete Response (CR) rate at the end of T-CHOP treatment.
Secondary outcome measures
Duration of Response (DoR)
Overall Response Rate (ORR) at the end of T-CHOP treatment.
Overall Survival (OS)
+1 more

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT04204057
29%
Anemia
24%
Neutropenia
19%
Alanine aminotransferase increased
19%
Aspartate aminotransferase increased
10%
Pneumonia
10%
Thrombocytopenia
10%
Diarrhea
10%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenalisib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tenalisib 800 mg BID and CHOPExperimental Treatment1 Intervention
Group II: Tenalisib 400 mg BID and CHOPExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenalisib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Rhizen Pharmaceuticals SALead Sponsor
16 Previous Clinical Trials
590 Total Patients Enrolled

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 Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL
2023. "Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05239910.
~0 spots leftby Dec 2026
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