NCT03629873

Brief Summary

This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects

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
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2018

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

February 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

3.9 years

First QC Date

August 5, 2018

Last Update Submit

December 30, 2021

Conditions

Lymphoma, Large B-Cell, DiffuseMantle Cell LymphomaPeripheral T Cell LymphomaDouble-hit Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate

    2 years after transplantation

Secondary Outcomes (4)

  • Overall survival

    2 years after transplantation

  • Complete remission

    3 months after transplantation

  • Time of hematopoietic reconstitution

    15 days, 1 month

  • Non-relapse mortality

    2 years

Interventions

ChidamideDRUG

Chidamide 30mg po d-7、-4、0、3; Carmustine 300mg/m\^2 IVD d-6; Etoposide 150mg/m\^2/d qd IVD d-5\~-2; Cytarabine 150mg/m\^2 q12h IVD d-5\~-2; Cyclophosphamide 1.0g/m\^2/d qd IVD d-5\~-2

Also known as: Carmustine, Etoposide, Cytarabine, Cyclophosphamide, Autologous hematopoeitic stem cell transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.
  • Adequate organ system function including:
  • Creatinine clearance rate ≥ 80ml/min and creatinine \< 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin \< 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia
  • Age 18-60 years, male and female
  • ECOG score 0-1
  • Number of neutrophil ≥ 1.5×10\^9/L, number of platelet ≥ 70×10\^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10\^6/kg
  • Expected survival ≥ 12 weeks
  • Volunteered to participate in this study and signed informed consent

You may not qualify if:

  • Have evidence of CNS lymphoma
  • Relapse after autologous hematopoietic stem cell transplantation
  • Active hepatitis B or hepatitis C virus infection
  • Severe active infection
  • HIV-infected persons
  • Liver cirrhosis or hepatic fibrosis
  • QTc \> 500ms
  • Have mental disorder or unable to sign informed consent
  • History of drug abuse and intemperance
  • Women who are pregnant or lactating or have breeding intent
  • The investigators believe that any increase in the risk of the subject or interference with the results of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, T-Cell, Peripheral

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

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
Professor

Study Record Dates

First Submitted

August 5, 2018

First Posted

August 14, 2018

Study Start

February 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Locations

CN(1)