Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy

STATUS

Recruiting
participants needed

28
sponsor

Ruijin Hospital

Send

Updated on 19 February 2024

See if I qualify

measurable disease

lymphoma

azacitidine

pet/ct scan

chidamide

peripheral t-cell lymphoma

t-cell lymphoma

tucidinostat

Summary

Show definitions

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.

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.

Details

Condition	Peripheral T-Cell Lymphoma, T-Cell Lymphoma, T-Cell Lymphoma
Age	18years - 100years
Treatment	Azacitidine, Chidamide
Clinical Study Identifier	NCT04480125
Sponsor	Ruijin Hospital
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
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 >2ADL100 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

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

peripheral t-cell lymphoma

t-cell lymphoma

tucidinostat

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy