Status:
UNKNOWN
Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL
Lead Sponsor:
Peking University
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Detailed Description
PRIMARY OBJECTIVES: To determine the objective response rate (ORR). SECONDARY OBJECTIVES: 1. To determine the complete response rate (CRR). 2. To determine the duration of response (DOR). 3. To det...
Eligibility Criteria
Inclusion
- 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；
- 18 ≤ 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.
Exclusion
- 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;
- Uncontrolled concomitant disease;
- Patients with active hepatitis. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 50 IU/mL) and HCV RNA (no more than the lower limit of the detection method);
- History of gastrointestinal perforation and /or fistula within 6 months before enrollment;
- Hemophagocytic syndrome；
- Uncontrolled third space effusion, e.g. ascites or pleural effusion cannot be drained or controlled;
- Women who are pregnant or nursing；
- According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions;
- Other researchers consider it unsuitable for patients to participate in this study.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04052659
Start Date
April 15 2021
End Date
December 30 2025
Last Update
March 9 2021
Active Locations (1)
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1
Beijing
Beijing, Beijing Municipality, China, 100000