NCT04480125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

July 19, 2020

Last Update Submit

April 19, 2022

Conditions

Peripheral T-cell Lymphoma

Keywords

Peripheral T-cell lymphomaTargeted therapyChemo-free therapy

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

    At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (7)

  • Overall response rate

    At the end of Cycle 6 (each cycle is 21 days)

  • Progression free survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Overall survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Duration of response

    Baseline up to data cut-off (up to approximately 4 years)

  • Treatment related mortality

    Baseline up to data cut-off (up to approximately 4 years)

  • +2 more secondary outcomes

Other Outcomes (2)

  • Circulating free Deoxyribonucleic Acid (cfDNA) monitoring

    Baseline up to data cut-off (up to approximately 4 years)

  • Exploratory biomarker analysis

    Baseline up to data cut-off (up to approximately 4 years)

Study Arms (1)

Aza+Chida

EXPERIMENTAL

Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses

Drug: AzacitidineDrug: Chidamide

Interventions

AzacitidineDRUG

100mg D1-7

Aza+Chida
ChidamideDRUG

30mg BIW PO

Aza+Chida

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

AzacitidineN-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Weili Zhao

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Weili Zhao, PhD，MD

CONTACT

+862164370045zwl_trial@163.com

Pengpeng Xu, PhD，MD

CONTACT

+862164370045pengpeng_xu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First Deputy Director，Hematology Department

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 21, 2020

Study Start

June 20, 2020

Primary Completion

June 20, 2022

Study Completion

June 20, 2024

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

CN(1)