Chidamide Plus R-CHOP in Elderly DLBCL

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753647
• Other study ID #: CR-CHOP
• Status: Recruiting
• Phase: Phase 2
• First received: April 19, 2016
• Last updated: November 10, 2017
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: November 2017
• Source: Ruijin Hospital
• Contact: Weili Zhao, MD,PhD
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive

• Age 61-75 years

• ECOG 0,1,2

• Life expectancy>6 months

• Informed consented

• IPI>1

Exclusion Criteria:

• Chemotherapy before

• 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

• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease

• Primary CNS lymphoma

• LVEF=50%

• Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*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

• Pregnant or lactation

• HIV infection

• If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab

• Cyclophosphamide

• Doxorubicin

• Vincristine

• Prednisone

• Chidamide

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary	Progression free survival rate		2 year
Secondary	Overall survival rate		2 year
Secondary	Overall response rate		21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0		Each cycle of treatment and then every 3 months for 2 years