Clinical trial NCT04480125: Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
Official title: The Efficacy and Safety of Azacitidine in Combination With Chidamide in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma Unfit for Conventional Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Keywords: Peripheral T-cell lymphoma
Targeted therapy
Chemo-free therapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 conventional chemotherapy.

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 with unfavourable prognosis, with 5-year overall survival rate of 38.5%. Elderly patients seldom benefit from conventional CHOP regimen. A study showed that CR rate was only 18.1% in elderly patients (median age of 80 years old, ranging from 56 to 93 years old).

Azacitidine combined with romidepsin has been proved efficient in relasped or refractory PTCL, with CR rate of 55%. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes:
measure: Overall response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: Progression free survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Treatment related mortality
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
timeFrame: : Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
Other outcomes:
measure: Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Exploratory biomarker analysis
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao
role: STUDY_CHAIR
References: