Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05949944

Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma

Led by Sun Yat-sen University · Updated on 2024-05-17

50

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.

CONDITIONS

Official Title

Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed peripheral T-cell lymphoma including PTCL NOS, angioimmunoblastic T-cell lymphoma, enteropathy related T-cell lymphoma, or liver spleen T-cell lymphoma
  • No prior anti-tumor treatment
  • At least one measurable or evaluable lesion by 2014 Lugano Lymphoma Evaluation Criteria
  • Age 18 years or older
  • ECOG performance status 0 to 2
  • Expected survival longer than 3 months
  • Adequate bone marrow and organ function
  • Not accompanied by hemophagocytic syndrome or treated and evaluated as suitable
  • Willing to participate and able to complete all study procedures with signed informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with PI3K inhibitors
  • History of other invasive cancers not relieved for over 3 years
  • Central nervous system involvement
  • Known allergies to study medications
  • Participation in other drug trials within 4 weeks prior to study
  • Pregnant or breastfeeding women
  • Active infections (except fever from tumor symptoms)
  • Conditions affecting oral medication intake such as inability to swallow, chronic diarrhea, or bowel obstruction
  • History of psychotropic substance abuse or mental disorders preventing participation
  • Severe or uncontrolled diseases including poorly controlled blood pressure, serious heart conditions, active interstitial lung diseases, significant liver disease, renal failure needing dialysis, uncontrolled fluid buildup requiring drainage, poorly controlled diabetes, or significant proteinuria
  • Immune deficiency disorders including HIV/AIDS or history of organ transplantation
  • Serious accompanying diseases that threaten safety or affect ability to complete the study as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

Q

Qingqing Cai, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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