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

March 4, 2020 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 On confirmation of PD , patients will be withdrawn from the trial and receive salvage regimens.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chidamide plus Sintilimab
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
200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment
Drug: Chidamide
20mg po per week continuously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
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
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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)
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
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
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)
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
PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Peking University Third Hospital
Dongzhimen Hospital, Beijing
Beijing Longfu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (ACTUAL)

March 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NHL-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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