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Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT04432402
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
WEI XU, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Lenalidomide Not Applicable

Detailed Description:
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Estimated Study Start Date : June 14, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Lenalidomide in Combination With R-GemOx
Lenalidomide 10mg、15mg、20mg、25mg qd PO d1-7 Rituximab 375mg/m2 ivd d0 Gemcitabine 1g/m2 ivd d1 Oxaliplatin 100mg/m2 ivd d1 every14 days as a cycle
Drug: Lenalidomide
Lenalidomide: 10mg、15mg、20mg、25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)
Other Name: Rituximab, Gemcitabine, oxaliplatin




Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: at the end of the first cycle of R2-GemOx (each cycle is 14 days) ]
    Maximum tolerated dose

  2. Dose limiting toxicity [ Time Frame: 28 days ]
    Dose limiting toxicity

  3. Dose limiting toxicity [ Time Frame: 2 years ]
    Dose limiting toxicity


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years ]
    progression-free survival

  2. overall survival [ Time Frame: 2 years ]
    overall survival



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma).
  2. Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≥ 2;
  3. Expected survival ≥ 12 weeks;
  4. At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm);
  5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements;
  6. All patients must agree to take effective contraceptive measures during the trial measures

Exclusion Criteria:

  1. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
  2. Patients known to have varicella or herpes zoster virus infection
  3. Previous exposure to any anti-tumor therapy
  4. Poor hepatic and/or renal function, unless these abnormalities were related to the lymphoma
  5. 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
  6. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months
  7. 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
  8. Central nervous system (CNS) or meningeal involvement
  9. Known sensitivity or allergy to investigational product
  10. Major surgery within three weeks
  11. Patients receiving organ transplantation
  12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
  13. Presence of Grade III nervous toxicity within past two weeks
  14. Active and severe infectious diseases
  15. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment
  16. In any conditions which investigator considered ineligible for this study.
  17. Histologic transformation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432402


Contacts
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Contact: Li Wang, M.D +862568136034 lilyw7878@163.com
Contact: Wei Xu, M.D., Ph.D +862568136034 xuwei0484@jsph.org.cn

Locations
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China, Jiangsu
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Li Wang, M.D., Ph.D    86 25 68306034    lilyw7878@163.com   
Contact: Wei Xu, M.D., Ph.D    86 25 68306034    xuwei10000@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Wei Xu, M.D., Ph.D The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04432402    
Other Study ID Numbers: 2019-SR-443
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by WEI XU, The First Affiliated Hospital with Nanjing Medical University:
R-Gemox
Lenalidomide
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Oxaliplatin
Lenalidomide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors