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

Phase 1

• Conditions: Diffuse Large B-cell Lymphoma Recurrent; Diffuse Large B Cell Lymphoma Refractory
• Interventions: Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Lenalidomide Oral Capsule

• Registration Number: NCT03795571
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R2-GOD	Gemcitabine	-
R2-GOD	Lenalidomide Oral Capsule	-
R2-GOD	Rituximab	-
R2-GOD	Oxaliplatin	-
R2-GOD	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose and dose limited toxicity	28 days after first cycle of R2-GOD regimen

Secondary Outcome Measures

Name	Time	Method
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 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
Overall survival	2 years	from the date of inclusion to date of death, irrespective of cause

Trial Locations

Locations (1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China