Chidamide Plus R-CHOP in Elderly DLBCL

Shanghai Jiao Tong University logo

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:
Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles
Treatment:
Drug: Cyclophosphamide
Drug: Chidamide
Drug: Doxorubicin
Drug: Prednisone
Drug: Vincristine
Drug: Rituximab

Trial contacts and locations

1

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Central trial contact

Pengpeng Xu, MD; Weili Zhao, MD,PhD

Data sourced from clinicaltrials.gov

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