PI3Kδ Inhibitor Parsaclisib Combined with Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

Last updated: March 24, 2025
Sponsor: Henan Cancer Hospital
Overall Status: Terminated

Phase

1/2

Condition

Non-hodgkin's Lymphoma

Lymphoma

T-cell Lymphoma

Treatment

Parsaclisib

Chidamide

Clinical Study ID

NCT05083208
HNSZLYYML06
  • Ages 18-75
  • All Genders

Study Summary

This is a prospective single-arm, multicenter, phase Ib/II clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral T-cell lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 to 75 years old (including 18 and 75)

  2. Agreeing to sign the written informed consents

  3. Diagnosed as peripheral T-cell lymphoma, including peripheral T-cell lymphoma,unspecified type, anaplastic large cell lymphoma (ALK negative or positive),angioimmunoblastic T-cell lymphoma, enteropathy Related T-cell lymphoma,hepatosplenic T-cell lymphoma, γ/δ T-cell lymphoma, NK/T-cell lymphoma, and othersubtypes of PTCL that the investigator judges to be suitable for participating inthis study

  4. Received at least first-line anti-tumor therapy in the past, whether or notChidamide has been used

  5. Having at least one measurable lesions

  6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2

  7. Life expectancy no less than 3 months

  8. enough main organ function

  9. Pregnancy test within 7 days must be negative for women of childbearing period, andappropriate measures should be taken for contraception for women in childbearingperiod during the study and six months after this study

  10. Agreeing to follow the trail protocol requirements

Exclusion

Exclusion Criteria:

  1. Types other than peripheral T-cell lymphoma listed in the enrollment criteria

  2. Diagnosed as central nervous system lymphoma

  3. Received palliative treatment for other malignant tumors in the past 2 years

  4. Uncontrolled active infection

  5. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heartinfarction less than 6 months

  6. The non-hematological toxicity caused by the previous anti-tumor treatment has notrecovered to ≤1 grade, and the hematological toxicity has not recovered to ≤2 grade

  7. Patients with a history of mental illness

  8. Those who are known to be allergic to the active ingredients or excipients of thedrug parsaclisib and chidamide

  9. Received PI3Kδ inhibitor treatment in the past

  10. Received autologous hematopoietic or allogeneic hematopoietic stem celltransplantation within 3 months

  11. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) >2

  12. There are factors that affect the absorption of oral drugs

  13. Pregnant or lactating women

  14. Researchers determine unsuited to participate in this trial

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Parsaclisib
Phase: 1/2
Study Start date:
February 20, 2022
Estimated Completion Date:
February 08, 2025

Connect with a study center

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

    Zhengzhou, Henan
    China

    Site Not Available

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