Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT03795571
Phase
PHASE1
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma Refractory
  • Diffuse Large B-cell Lymphoma Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375mg/m2，d0
  • Gemcitabine — DRUG
    Gemcitabine 1000mg/m2，d1，d5
  • Oxaliplatin — DRUG
    Oxaliplatin 75mg/m2，d1
  • Dexamethasone — DRUG
    Dexamethasone 40mg/d，d1\~d4
  • Lenalidomide Oral Capsule — DRUG
    Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1\~d10； 21days a cycle

Study Details

Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and Refractory DLBCL.The investigators therefore design this phase I study to investigate the safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.

Key Dates

Start date
Jan 1, 2019
Status verified
Feb 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

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

Arms

  • Experimental: R2-GOD

Primary Outcome Measure

maximum tolerated dose and dose limited toxicity [ Time Frame: 28 days after first cycle of R2-GOD regimen ]

Central Contacts

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