## Protocol Section
### Identification Module
**NCT ID:** NCT06421948

**Brief Title:** Linperlisib Combined With Chidamide in Patients With PTCL

**Official Title:** PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study

#### Organization Study ID Info
**ID:** HNSZLYYML08
#### Organization
**Class:** OTHER_GOV
**Full Name:** Henan Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2026-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Yanyan Liu

#### Responsible Party

**Investigator Affiliation:** Henan Cancer Hospital

**Investigator Full Name:** Yanyan Liu

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to determine the maximum tolerated dose (MTD) of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma (PTCL), and to compare the combination of linperlisib and chidamide to standard CHOP (cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone) regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better.

**Detailed Description:** In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the optimal dose of linperlisib.

In the phase II trial, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP regimen chemotherapy.

Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait.

### Conditions Module

**Conditions:**

- Peripheral T-cell Lymphoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive a combination of linperlisib in combination with chidamide orally.

**Intervention Names:**

- Drug: Linperlisib and chidamide

**Label:** Orally administered, targeted therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive standard CHOP regimen chemotherapy including cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone.

**Intervention Names:**

- Drug: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone

**Label:** Intravenously chemotherapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Orally administered, targeted therapy

**Description:** A combination of linperlisib and chidamide will be administered for 6 cycles in patients responded to treatment.

**Name:** Linperlisib and chidamide

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Intravenously chemotherapy

**Description:** A combination of cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone (CHOP) will be administered for 6 cycles in patients responded to treatment.

**Name:** cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Complete response rate

**Measure:** CRR

**Time Frame:** Through study completion, an average of 3 years

#### Secondary Outcomes

**Description:** Progression-free survival

**Measure:** PFS

**Time Frame:** 12 months

**Description:** Overall survival

**Measure:** OS

**Time Frame:** 12 months

**Description:** Adverse event

**Measure:** AE

**Time Frame:** Through study completion, an average of 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib study)
* Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma and NK/T-cell lymphoma are not included.
* ECOG PS 0-2 at protocol entry
* Estimated life expectancy of 6 months or longer
* Measurable disease
* Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
* Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
* Written informed consent

Exclusion Criteria:

* Patients previously treated with PI3K inhibitor
* Patients previously treated with chidamide (phase Ib study is not limited by this item)
* Suspected or documented central nervous system involvement by lymphoma
* Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
* Patients with active, uncontrolled infections
* Unwillingness or inability to comply with the protocol
* Deemed 'unfit' by the treating physician
* Pregnant and/or breastfeeding women
* Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
* Patients with contraindications to chemotherapy
* Known hypersensitivity to one or more of the study drugs

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yyliu@zzu.edu.cn

**Name:** Yanyan Liu

**Phone:** 86 037165587791

**Role:** CONTACT

**Contact 2:**

**Email:** zlyyyanzheng3920@zzu.edu.cn

**Name:** Zheng Yan

**Phone:** 86 13598097015

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zhengzhou

**Contacts:**

***Contact 1:***

- **Email:** yyliu@zzu.edu.cn

- **Name:** Yanyan Liu

- **Phone:** 86-037165587791

- **Role:** CONTACT

***Contact 2:***

- **Email:** zlyyyanzheng3920@zzu.edu.cn

- **Name:** Zheng Yan

- **Phone:** 86+13598097015

- **Role:** CONTACT

**Country:** China

**Facility:** Affiliated Cancer Hospital of Zhengzhou University

**State:** Henan

**Status:** RECRUITING

**Zip:** 450008

#### Overall Officials

**Official 1:**

**Affiliation:** A

**Name:** Yanyan Liu

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: HIGH

- As Found: Peripheral T-cell Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: HIGH

- As Found: Peripheral T-cell Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000016399

- Term: Lymphoma, T-Cell

- ID: D000016411

- Term: Lymphoma, T-Cell, Peripheral

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019653

- Term: Myeloablative Agonists

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M6727

- Name: Cyclophosphamide

- Relevance: HIGH

- As Found: Cycle

- ID: M7492

- Name: Doxorubicin

- Relevance: HIGH

- As Found: Women

- ID: M227339

- Name: Liposomal doxorubicin

- Relevance: LOW

- As Found: Unknown

- ID: M14121

- Name: Prednisone

- Relevance: HIGH

- As Found: Min

- ID: M17495

- Name: Vincristine

- Relevance: HIGH

- As Found: Volume

- ID: M17954

- Name: Epirubicin

- Relevance: HIGH

- As Found: Mass

- ID: M28511

- Name: Histone Deacetylase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011241

- Term: Prednisone

- ID: D000003520

- Term: Cyclophosphamide

- ID: D000004317

- Term: Doxorubicin

- ID: D000014750

- Term: Vincristine

- ID: D000015251

- Term: Epirubicin

### Misc Info Module

- Version Holder: 2024-05-31
