NCT03373019

Brief Summary

The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

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
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2017

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 30, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

1.5 years

First QC Date

November 30, 2017

Last Update Submit

December 12, 2017

Conditions

ChidamideLymphoma, B-CellLymphoma, Large B-Cell, DiffuseNeoplasm by HistologyNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinCyclophosphamideRituximabGemcitabineCisplatinDexamethasoneHDAC Inhibitor

Keywords

chidamideR-GDPdiffuse large B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • ORR

    overall response rate

    6 weeks

Secondary Outcomes (4)

  • CR

    6 weeks

  • OS

    3 years

  • 3 year PFS

    3 years

  • adverse event

    throughout the treatment period，up to 6 months

Study Arms (1)

Chidamide combined with R-GDP

EXPERIMENTAL

Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off

Drug: Chidamide combined with R-GDP

Interventions

Chidamide combined with R-GDPDRUG

Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off

Chidamide combined with R-GDP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages: 18-75 years old
  • Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy
  • Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) index \< 2
  • Informed consent available
  • Life expectancy of more than 3 months;
  • Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
  • Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
  • Liver function: total bilirubin, ALT and AST were \<1.5 × UNL (the upper limit of normal value)
  • Renal function: Cr\<1.5 × UNL and creatinine clearance \> 50ml/min

You may not qualify if:

  • Prior history of treatment of HDAC inhibitor.
  • Plan of HSCT in the future
  • Significant pericardial effusion showed by chest CT scan
  • Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation
  • Syphilis or human immunodeficiency virus (HIV) infection
  • Pregnant or lactating women
  • History of organ transplantation
  • Serious active infections (including hepatitis)
  • Serious neurological or psychiatric history, including dementia or epilepsy.
  • Termination criteria:
  • Withdrew consent
  • Researchers think it is necessary to terminate the study;
  • Disease progression or death;
  • Poor compliance
  • Subclinical or clinical cardiac toxicity;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kai Xue

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Kai Xue

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Large B-Cell, DiffuseNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeHemic and Lymphatic Diseases

Central Study Contacts

Kai Xue, MD

CONTACT

13818659448xuekaishanghai@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
Dr

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 14, 2017

Study Start

December 21, 2017

Primary Completion

June 30, 2019

Study Completion

March 1, 2021

Last Updated

December 14, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)