Status:
UNKNOWN
Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Diffuse Large B-cell Lymphoma Recurrent
Diffuse Large B Cell Lymphoma Refractory
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03795571
Start Date
January 1 2019
End Date
December 31 2019
Last Update
February 15 2019
Active Locations (1)
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1
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital
Nanjing, Jiangsu, China, 210000