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

Primary Purpose

Cutaneous T-cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Chidamide
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-cell Lymphoma focused on measuring Chidamide, Sintilimab, cutaneous T-cell lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide plus Sintilimab

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response.

Secondary Outcome Measures

Adverse Events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Duration of response (DOR)
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
Progression-Free Survival (PFS)
PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause.

Full Information

First Posted
March 3, 2020
Last Updated
March 4, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
Peking University Third Hospital, Beijing Longfu Hospital, Dongzhimen Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT04296786
Brief Title
Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study
Official Title
Sintilimab Combined With Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Single Arm Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Peking University Third Hospital, Beijing Longfu Hospital, Dongzhimen Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a single-arm phase 2 study with fixed does of combined Sintilimab and Chidamide regimen. This regimen is repeated every 21 days. Sintilimab (200mg) is administered intravenously on day 1 of every cycle. Chidamide is used 20mg twice per week continuously. From the beginning of the trial, sindilimab will be used for 96 weeks, until disease progress, intolerable toxicity or patient/investigator discretion. Patients will continue to receive Chidamide treatment until disease progression, unacceptable toxicity, or patient/investigator discretion. 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. The patients who achieve complete remission (CR), partial remission (PR), and stable disease (SD) will receive further treatment. The patients with progressed disease (PD) will be continue on the treatment and reassess after 4-8 weeks to rule out false progression. On confirmation of PD , patients will be withdrawn from the trial and receive salvage regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma
Keywords
Chidamide, Sintilimab, cutaneous T-cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide plus Sintilimab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
20mg po per week continuously
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR was defined as the proportion of patients who achieved CR or PR as their best response.
Time Frame
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 Outcome Measure Information:
Title
Adverse Events
Description
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
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
Title
Duration of response (DOR)
Description
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
Time Frame
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
Title
Progression-Free Survival (PFS)
Description
PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Wei
Phone
+86 136 8147 3557
Email
vv1223@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Wei Chong
Phone
+86 13521760705
Email
QH5035@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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