Clinical trial NCT04296786: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cutaneous T-cell Lymphoma
Keywords: Chidamide
Sintilimab
cutaneous T-cell lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Beijing Longfu Hospital
name: Dongzhimen Hospital, Beijing
First posted: 2020-03-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 On confirmation of PD , patients will be withdrawn from the trial and receive salvage regimens.

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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 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:
measure: Adverse Events
timeFrame: 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
measure: Duration of response (DOR)
timeFrame: 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
measure: Progression-Free Survival (PFS)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: