Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study

NCT04296786 | Unknown Phase 2

• 1 other identifier: PUMCH-NHL-006
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.

Conditions

Cutaneous T-cell Lymphoma

Keywords

Chidamide; Sintilimab; cutaneous T-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the proportion of patients who achieved CR or PR as their best response.

  From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks

Secondary Outcomes (3)

• Adverse Events

  From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks

• Duration of response (DOR)

  From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks

• Progression-Free Survival (PFS)

  PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause, whichever came first, assessed up to 104 weeks

Study Arms (1)

Chidamide plus Sintilimab

EXPERIMENTAL

Patients in experimental group will receive fixed does of Sintilimab and Chidamide. This regimen is repeated every 21 days. The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment.

Drug: Sintilimab; Drug: Chidamide

Interventions

Sintilimab DRUG

200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment

Chidamide plus Sintilimab

Chidamide DRUG

20mg po per week continuously

Chidamide plus Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed cutaneous T-cell lymphoma according World Health Organization (WHO) classification.
• ECOG≤2
• Patients with measurable lesions, with or without extra-dermal lesions, clinical stage of IIB-IVB.
• Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment.
• Absolute neutrophil count (ANC）≥0.75×109/L，platelet (PLT) ≥ 50×109/L，hemoglobin (HGB）≥ 80 g/L
• Thyroid stimulating hormone (TSH) within normal range

You may not qualify if:

• Pre-existing uncontrolled active infection
• Alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN), total bilirubin (TBIL) \>1.5 times ULN, serum creatinine \>1.5 times ULN
• Patients with clinically significant QT interval prolongation (male \> 450ms, female \> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), acute coronary syndrome (ACS) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease.
• Patients who have received organ transplantation or hematopoietic stem cell transplantation.
• Active bleeding or recent thrombotic disease
• Patients with known interstitial lung disease
• Patients with active autoimmune disease or history of autoimmune disease in the past 2 years
• Patients with CNS involvement
• Pregnant or lactating women
• History of mental illness

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University Third Hospital: collaborator
• Beijing Longfu Hospital: collaborator
• Dongzhimen Hospital, Beijing: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

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

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: November 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: March 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)