Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL (R2-GOD)

Nanjing Medical University

Status and phase

Unknown

Phase 1

Conditions

Diffuse Large B Cell Lymphoma Refractory

Diffuse Large B-cell Lymphoma Recurrent

Treatments

Drug: Rituximab

Drug: Oxaliplatin

Drug: Gemcitabine

Drug: Lenalidomide Oral Capsule

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT03795571

R2-GOD regimen

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.