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

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05083208
Collaborator
(none)
28
1
1
60
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Arm, Single-center, Phase Ib/II Clinical Trial of PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: PI3Kδ inhibitor Parsaclisib plus Chidamide

Phase Ib (Explored the appropriate dose of Parsaclisib in combination with chidamide) Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib within the first 8 weeks. Maintain treatment: 2.5mg orally every day continuously, at approximately the same time every day, without food restriction, once a day. Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast.

Drug: Parsaclisib
Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib within the first 8 weeks (including the treatment received in Phase Ib). Maintain treatment: 2.5mg orally every day continuously, at approximately the same time every day, without food restriction, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years.
Other Names:
  • IBI376
  • PI3K inhibitor
  • Drug: Chidamide
    Phase Ib: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast. Phase II: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast until disease progression, death or unacceptable toxicity developments.

    Outcome Measures

    Primary Outcome Measures

    1. objective response rate [every 8 or 12 weeks from the day of the first cycle to 2 years after the last patient's enrollment (each cycle is 28 days).]

      the total proportion of patients with complete response (CR) and partial response (PR)

    Secondary Outcome Measures

    1. 2-year progression-free survival [from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days).]

      the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

    2. 2-year overall survival [from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years after last patient's enrollment (each cycle is 28 days).]

      from date of first day of treatment to the date of death by any cause

    3. incidence and relationship with study drugs of grade 3-4 adverse events [from the date of the first cycle of treatment to 2 years after last patient's enrollment (each cycle is 28 days).]

      the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 other subtypes of PTCL that the investigator judges to be suitable for participating in this study

    4. Received at least first-line anti-tumor therapy in the past, whether or not Chidamide 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, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study

    10. Agreeing to follow the trail protocol requirements

    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 heart infarction less than 6 months

    6. The non-hematological toxicity caused by the previous anti-tumor treatment has not recovered 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 the drug parsaclisib and chidamide

    9. Received PI3Kδ inhibitor treatment in the past

    10. Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months

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

    2

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

    2. Pregnant or lactating women

    3. Researchers determine unsuited to participate in this trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Zhengzhou Henan China

    Sponsors and Collaborators

    • Henan Cancer Hospital

    Investigators

    • Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanyan Liu, Director, Henan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05083208
    Other Study ID Numbers:
    • HNSZLYYML06
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yanyan Liu, Director, Henan Cancer Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 28, 2021