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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Gemcitabine; Lenalidomide; Oxaliplatin; Rituximab; Thalidomide

Criteria

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.