Diffuse Large B Cell Lymphoma
Conditions
Brief summary
This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients
Interventions
Lenalidomide 25mg/d PO d1-10 Plus 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 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5\*\[GFR(ml/min)+25\]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3,
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls) Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL. No history of stem cell transplantation. Written informed consent.
Exclusion criteria
Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. Clinically significant active infection. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. Patients who are pregnant or breast-feeding. HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival rate | 1 year |
| Overall survival rate | 1 year |
| Overall response rate | 12 weeks |
Countries
China
Contacts
Primary ContactWeili Zhao, MD, PhD
Backup ContactZhong Zheng, MD
Outcome results
None listed