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Peripheral T-Cell LymphomaPhase 1NCT05083208

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

A Phase 1 study testing Parsaclisib and Chidamide in people with Peripheral T-Cell Lymphoma, run by Henan Cancer Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peripheral T-Cell Lymphoma
What is being tested?
Parsaclisib and Chidamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
20 Feb 2022to 1 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 75 years old (including 18 and 75)
  • Agreeing to sign the written informed consents
  • 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
  • Received at least first-line anti-tumor therapy in the past, whether or not Chidamide has been used
  • Having at least one measurable lesions
  • World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
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  • Life expectancy no less than 3 months
  • enough main organ function
  • 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
  • Agreeing to follow the trail protocol requirements

Who cannot join

  • Types other than peripheral T-cell lymphoma listed in the enrollment criteria
  • Diagnosed as central nervous system lymphoma
  • Received palliative treatment for other malignant tumors in the past 2 years
  • Uncontrolled active infection
  • Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
  • 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
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  • Patients with a history of mental illness
  • Those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide
  • Received PI3Kδ inhibitor treatment in the past
  • Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months
  • World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) >2
  • There are factors that affect the absorption of oral drugs
  • Pregnant or lactating women
  • Researchers determine unsuited to participate in this trial

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Single Arm, Multi-center, Phase Ib Clinical Trial of PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

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

Being tested
Parsaclisib, Chidamide
Keywords
Relapsed/Refractory Peripheral T-cell Lymphoma, PI3Kδ inhibitor, Chidamide
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParsaclisibDrug

    Also called IBI376, PI3K inhibitor

    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. Patients without progression or unacceptable toxicity after 8 weeks enter maintenance treatment.

    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.

  • ChidamideDrug

    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, until progression or intolerance.

Study groups in NCT05083208
Study groupRoleWhat they receive
PI3Kδ inhibitor Parsaclisib plus ChidamideExperimentalParsaclisib 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.
Receives: Drug: Parsaclisib; Drug: Chidamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of Parsaclisib in Combination with Chidamide

    This outcome measure will evaluate the safety and tolerability of parsaclisib when administered in combination with chidamide. Safety will be assessed by monitoring adverse events (AEs), dose-limiting toxicities (DLTs), and other clinically significant toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE). Tolerability will be assessed based on the occurrence and severity of AEs during the trial, as well as the ability of patients to complete the treatment regimen without discontinuation due to adverse effects.

    Measured: Approximately 2 years

  2. Recommended Phase 2 Dose (RP2D) of Parsaclisib in Combination with Chidamide

    This outcome measure will determine the recommended Phase 2 dose (RP2D) of parsaclisib when combined with a fixed dose of 20 mg of chidamide administered twice weekly (BIW). The RP2D will be determined based on dose escalation, safety data, and the tolerability observed in the Phase Ib portion of the study. The RP2D will be the highest dose level at which no more than 33% of patients experience dose-limiting toxicities (DLTs) within the first treatment cycle.

    Measured: Approximately 2 years

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    The objective response rate will be calculated by dividing the number of patients who achieve CR or PR by the total number of patients in the study population.

    Measured: Through study completion, approximately 2 years

  2. Complete Response Rate (CRR)

    CRR will be reported as the proportion of patients who achieve CR among the total number of patients treated.

    Measured: Through study completion, approximately 2 years

  3. 1-year progression-free survival

    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

    Measured: 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).

  4. 1-year overall survival

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

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start20 Feb 2022
  3. Primary completion30 Jun 2024
  4. Study completion1 Aug 2025

Why it stopped: The clinical development of parsaclisib was stopped by it's manufacturer.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05083208
Sponsor's protocol ID
HNSZLYYML06
Status last verified
May 2024
First submitted
18 Sep 2021
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Luo X, Yan Z, Fang W, Duan H, Zhang Q, Wang H, Yao S, Zhang J, Jin Y, Li W, Teng X, Zhang L, Liang L, Lin Q, Wang P, Si H, Miao J, Zhou W, Yao Z, He YW, Xia Q, Liu Y. All-Oral PI3Kdelta and HDAC Inhibition with Parsaclisib Plus Chidamide and Step-Down Maintenance in Relapsed or Refractory Peripheral T-Cell Lymphoma: A Phase Ib Trial. MedComm (2020). 2026 Oct 2;7(10):e70993. doi: 10.1002/mco2.70993. eCollection 2026 Oct.

    PubMed 42827632

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Parsaclisib and Chidamide in people with Peripheral T-Cell Lymphoma, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The clinical development of parsaclisib was stopped by it's manufacturer.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Parsaclisib in Combination with Chidamide (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05083208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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