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

NCT04432402 | Unknown

• 1 other identifier: 2019-SR-443
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

R-Gemox; Lenalidomide

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose

  Maximum tolerated dose

  at the end of the first cycle of R2-GemOx (each cycle is 14 days)

• Dose limiting toxicity

  Dose limiting toxicity

  28 days

• Dose limiting toxicity

  Dose limiting toxicity

  2 years

Secondary Outcomes (2)

• progression-free survival

  2 years

• overall survival

  2 years

Study Arms (1)

Lenalidomide in Combination With R-GemOx

EXPERIMENTAL

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

Interventions

Lenalidomide DRUG

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)

Also known as: Rituximab, Gemcitabine, oxaliplatin

Lenalidomide in Combination With R-GemOx

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
• Patients known to have varicella or herpes zoster virus infection
• Previous exposure to any anti-tumor therapy
• Poor hepatic and/or renal function, 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
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months
• 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
• Central nervous system (CNS) or meningeal involvement
• Known sensitivity or allergy to investigational product
• Major surgery within three weeks
• Patients receiving organ transplantation
• 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
• Presence of Grade III nervous toxicity within past two weeks
• Active and severe infectious diseases
• Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Lenalidomide; Rituximab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Coordination Complexes

Study Officials

• Wei Xu, M.D., Ph.D

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Wang, M.D

CONTACT

+862568136034; lilyw7878@163.com

Wei Xu, M.D., Ph.D

CONTACT

+862568136034; xuwei0484@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: June 14, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)