Chidamide Plus R-CHOP in Elderly DLBCL

Sponsor
Ruijin Hospital
Study ID
NCT02753647
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
61 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
  • Cyclophosphamide — DRUG
  • Doxorubicin — DRUG
  • Vincristine — DRUG
  • Prednisone — DRUG
  • Chidamide — DRUG

Study Details

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.

Key Dates

Start date
Apr 30, 2016
Status verified
Nov 2017
Primary completion
Oct 31, 2018
Completion
Apr 30, 2019

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chidamide plus R-CHOP
    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

Primary Outcome Measure

Complete response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]

Central Contacts

Related Studies