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

February 13, 2019 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R2-GOD
Drug: Rituximab
Rituximab 375mg/m2，d0
Drug: Gemcitabine
Gemcitabine 1000mg/m2，d1，d5
Drug: Oxaliplatin
Oxaliplatin 75mg/m2，d1
Drug: Dexamethasone
Dexamethasone 40mg/d，d1~d4
Drug: Lenalidomide Oral Capsule
Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1~d10； 21days a cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum tolerated dose and dose limited toxicity
Time Frame: 28 days after first cycle of R2-GOD regimen
28 days after first cycle of R2-GOD regimen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate,
Time Frame: 6 months
overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen
6 months
Progressive free survival
Time Frame: 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
2 years
Overall survival
Time Frame: 2 years
from the date of inclusion to date of death, irrespective of cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2-GOD regimen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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