Diffuse Large B-cell Lymphoma Recurrent, Diffuse Large B Cell Lymphoma Refractory
Conditions
Keywords
lenalidomide, R-GOD, DLBCL
Brief summary
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.
Interventions
DRUGRituximab
Rituximab 375mg/m2，d0
DRUGGemcitabine
Gemcitabine 1000mg/m2，d1，d5
DRUGOxaliplatin
Oxaliplatin 75mg/m2，d1
DRUGDexamethasone
Dexamethasone 40mg/d，d1\ d4
DRUGLenalidomide Oral Capsule
Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1\ d10； 21days a cycle
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years old; * ECOG PS 0- 2; * Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma),relapse or refractory,defined as: * relapse after standard first-line immunochemotherapy( R-CHOP or R-CHOP like) * SD as best response after 4 cycles or PD after 2 cycles of first-line immunochemotherapy; * a measurable or evaluable disease at the time of enrollment(diameter ≥ 1.5cm）； * Eligible for subsequent autologous stem cell transplantation； * Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures * Expected survival ≥ 12 weeks； * Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements
Exclusion criteria
* Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures； * Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons； * Used of systemic anti-tumor treatment within four weeks； * CNS or meningeal involvement; * Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr\< 50 mL/min unless these abnormalities were related to the lymphoma; * Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration; * New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia； * Known sensitivity or allergy to investigational Product; * Major surgery within three weeks; * Presence of Grade III nervous toxicity within past two weeks; * Active and severe infectious diseases; * History of DVT or PE within past 12 months； * Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment; * In any conditions which investigator considered ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose and dose limited toxicity | 28 days after first cycle of R2-GOD regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate, | 6 months | overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen |
| Progressive free survival | 2 years | from date of inclusion to date of progression, relapse, or death from any causePFS：from date of inclusion to date of progression, relapse, or death from any cause |
| Overall survival | 2 years | from the date of inclusion to date of death, irrespective of cause |
Countries
China
Contacts
Primary ContactHuayuan Zhu, PhD& MD
Outcome results
None listed