Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Convention… (NCT04480125) | Clinical Trial Compass
UnknownPhase 2
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
China28 participantsStarted 2020-06-20
Plain-language 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 conventional chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Complete response rate
Timeframe: At the end of Cycle 6 (each cycle is 21 days)