Status:
UNKNOWN
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
Lead Sponsor:
Ruijin Hospital
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for c...
Detailed Description
Peripheral T-cell lymphoma (PTCL is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for \~10%. CHOP regimen has been widely used in PTCL patients even wi...
Eligibility Criteria
Inclusion
- Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG \>2，ADL\<100 or CCI\>1.
- Must has measurable lesion in CT or PET-CT prior to treatment
- Expected lifetime ≥ 3 months
- Informed consented
Exclusion
- Has accepted localized or systemic anti-lymphoma treatment
- Has accepted autologous Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS lymphoma
- Left EF≤ 50%
- Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/ L ;Platelet\<75\*10\^9/L; ALT or AST \>2\*ULN; Creatinine\>1.5\*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Not able to comply to the protocol for mental or other unknown reasons
- Patients with mentally disorders or other reasons unable to fully comply with the study protocol
- Pregnant or lactation
- HIV infection
- HBV-DNA and HCV-RNA undectable.
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04480125
Start Date
June 20 2020
End Date
June 20 2024
Last Update
April 20 2022
Active Locations (1)
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1
Shanghai Ruijin Hospital
Shanghai, China