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Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

NCT04204057 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-08-13

Study results available
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Summary

The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

DRUG

Tenalisib

Tenalisib 800 mg BID, Orally

Sponsors & Collaborators

  • Rhizen Pharmaceuticals SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2020-10-02
Completion
2020-10-02
FDA Drug
Yes

Countries

  • Bulgaria
  • Georgia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204057 on ClinicalTrials.gov