Chidamide Plus R-CHOP in Elderly DLBCL

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 2

Conditions

Diffuse Large B-cell Lymphoma

Treatments

Drug: Rituximab

Drug: Prednisone

Drug: Vincristine

Drug: Doxorubicin

Drug: Chidamide

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02753647

CR-CHOP

Details and patient eligibility

About

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.

Enrollment

49 estimated patients

Sex

All

Ages

61 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 1 patient group

Chidamide plus R-CHOP

Experimental group

Description: