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Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT03795571•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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;
+4 more criteria

Locations (1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

January 1, 2019

Primary Completion Date

December 31, 2019

Completion Date

December 31, 2019

Last Updated

February 15, 2019

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-cell Lymphoma RecurrentDiffuse Large B Cell Lymphoma Refractory

Interventions

Rituximab

DRUG

Gemcitabine

DRUG

Oxaliplatin

DRUG

Dexamethasone

DRUG

Lenalidomide Oral Capsule

DRUG

Contacts

Huayuan Zhu, PhD& MD

CONTACT

86 25 68306034 huayuan.zhu@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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