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

Study Overview
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Brief Summary
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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.

Official Title
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Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone (R2-GOD) in Treatment of Relapse/Refractory DLBCL:A Phase I Study

Conditions
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Diffuse Large B-cell Lymphoma Recurrent, Diffuse Large B Cell Lymphoma Refractory

Intervention / Treatment
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* Drug: Rituximab
* Drug: Gemcitabine
* Drug: Oxaliplatin
* Drug: Dexamethasone
* Drug: Lenalidomide Oral Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R2-GOD<br> | Drug: Rituximab<br>* Rituximab 375mg/m2，d0<br>Drug: Gemcitabine<br>* Gemcitabine 1000mg/m2，d1，d5<br>Drug: Oxaliplatin<br>* Oxaliplatin 75mg/m2，d1<br>Drug: Dexamethasone<br>* Dexamethasone 40mg/d，d1 d4<br>Drug: Lenalidomide Oral Capsule<br>* Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1 d10； 21days a cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose and dose limited toxicity |  | 28 days after first cycle of R2-GOD regimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate, | overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen | 6 months | 
| Progressive free survival | 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 | 2 years | 
| Overall survival | from the date of inclusion to date of death, irrespective of cause | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lenalidomide, R-GOD, DLBCL