Decitabine Plus R-CHOP in Diffuse Large B-cell Lymphoma

Sponsor
Ruijin Hospital
Study ID
NCT02951728
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

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

Study Details

This is a Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma

Key Dates

Start date
Oct 31, 2016
Status verified
Mar 2020
Primary completion
May 31, 2019
Completion
Oct 31, 2020

Study Design

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

Arms

  • Experimental: Decitabine plus R-CHOP
    Rituximab 375 mg/m2 IV d6; Cyclophosphamide 750mg/m2 IV d7; Doxorubicin 50mg/m2 IV d7; Vincristine 1.4 mg/m2 IV d7; Prednisone 60 mg/m2 PO d7-11; Decitabine will be administered intravenously at dose levels as follow in Phase 1: Dose level 1: Decitabine 10 mg/m2 days 1-5; Dose level 2: Decitabine 15 mg/m2 days 1-5; Dose level 3: Decitabine 20 mg/m2 days 1-5 and determine the maximum tolerated dose. In phase 2, Decitabine will be administered intravenously at MTD.

Primary Outcome Measure

maximum tolerated dose [ Time Frame: day1 to 21 ]

Related Studies