Loading clinical trials...

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma

NCT02567656•Rhizen Pharmaceuticals SA

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.

Detailed Description

Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)
•Refractory to or relapsed after at least 1 prior treatment line.
•ECOG performance status ≤2
•Patients must be ≥18 years of age
•Able to give a written informed consent.

Exclusion Criteria

•Any cancer therapy in the last 3 weeks or limited palliative radiation \<2 weeks
•Patients with HBV, HCV or HIV infection
•Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months
•Patients on immunosuppressive therapy including systemic corticosteroids.
•Patients with known history of liver disorders.
•Patients with uncontrolled Diabetes Type I or Type II
•Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
•Women who are pregnant or lactating.

Locations (8)

City of Hope

Duarte, California, United States

Chao Family Comprehensive Cancer Center University of California Irvine

Orange, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Emory University School of Medicine

Atlanta, Georgia, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

March 1, 2018

Completion Date

December 10, 2018

Last Updated

January 13, 2020

Enrollment

ACTUAL participants

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, Cutaneous

Interventions

RP6530

DRUG

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

NCT06561048

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell Lymphoma+5 more

View study

RECRUITINGPHASE3

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

NCT06947967

Lymphoma, T-Cell, Peripheral

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin

Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides

T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas

AEDV Registry of Primary Cutaneous Lymphoma