Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL

NCT04052659 | Unknown Phase 2

• 1 other identifier: CIBI308Y016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) by Lugano 2014 up to 24 months

  Proportion of subjects who achieve complete response (CR) or partial response (PR) by Lugano 2014 response criteria

  Up to 24 months

Secondary Outcomes (5)

• Complete remission rate (CRR) by Lugano 2014 up to 24 months

  Up to 24 months

• Duration of response (DOR) up to 24 months

  Up to 24 months

• Progression free survival (PFS) up to 24 months

  Up to 24 months

• Overall survival (OS) up to 24 months

  Up to 24 months

• Incidence and Severity of adverse events by CTCAE v5.0 up to 90 days post-treatment

  Up to 90 days post-treatment

Other Outcomes (1)

• Identification of potential biomarkers predictive of response to treatment

  Up to 24 months

Study Arms (1)

Treatment (sintilimab,chidamide and azacitidine)

EXPERIMENTAL

Sintilimab: 200 mg IV, Q3W, d1 Chidamid: 30 mg PO, BIW, d1, d4 Azacidine: 100 mg SC, Q3W, d1-7

Drug: Sintilimab; Drug: Chidamide; Drug: Azacidine

Interventions

Sintilimab DRUG

200 mg IV, every 3 weeks, d1

Also known as: IBI308

Treatment (sintilimab,chidamide and azacitidine)

Chidamide DRUG

30 mg PO, 2 times every week, d1 and d4

Also known as: Epidaza

Treatment (sintilimab,chidamide and azacitidine)

Azacidine DRUG

100 mg SC, every 3 weeks, d1 to d7

Also known as: Ladakamycin

Treatment (sintilimab,chidamide and azacitidine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed PTCL;
• Disease status defined as relapsed or refractory after \>=1 prior treatment lines;
• Prior use of HDACi or PD-1/PD-L1 antibodies or demethylation drugs is allowed;
• At least one measurable disease (defined as ≥ 1.5 cm in length-diameter, or 1.1\~1.5 cm in length-diameter and \>1.0 cm in short-diameter ) ；
• ECOG PS 0\~2；
• Provide written informed consent for the trial；
• ≤ age ≤ 80；
• Life expectancy ≥12 weeks;
• Adequate organ and bone marrow function, laboratory tests should be received within 7 days prior to the use of the research drug and meet the eligibility requirements;
• Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 120 days after the last dose of study medication.

You may not qualify if:

• Known central nervous system lymphoma or cutaneous T-cell lymphoma;
• Received any immunesuppressive drugs within 4 weeks of the first dose of study medicationy, not including topical corticosteroids or systemic corticosteroids in physiological doses (≤10 mg/day prednisone or equivalent dose of other steroid);
• Patients with active autoimmune diseases requiring systematic treatment in the past two years;
• Received or plan to receive any attenuated vaccines within 4 weeks of the first dose of study medication;
• Received the last anti-tumor therapy within 4 weeks of the first dose of study medication or have not recovered (recovery defined as baseline or ≤ grade 1) from adverse events due to anti-cancer agents;
• Currently participating in an interventional clinical study, unless participating in observational study or during follow-up period of an interventional study;
• Received any investigational agent within 4 weeks of the first dose of study medication;
• Subjects with interstitial lung disease or lung disease that may interfere with the detection or treatment of suspected drug-related pulmonary toxicity;
• Other primary malignancy;
• Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation;
• Received autologous hemopoietic stem cell transplantation within 90 days of the first dose of study medication;
• Received major surgery or unhealed wound, ulcer or fracture within 4 weeks of the first dose of study medication;
• Active tuberculosis；
• Known primary immunodeficiency；
• Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

sintilimab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Azacitidine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Yuqin Song, Doctor

  Cancer Hospital of Beijing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqin Song, Doctor

CONTACT

010-88196115; songyuqin622@163.com

Zhitao Ying, Doctor

CONTACT

010-88196115; yingzhitao001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 12, 2019
• Study Start: April 15, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)