search
Back to results

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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring R-Gemox, Lenalidomide

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide in Combination With R-GemOx

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum tolerated dose
Maximum tolerated dose
Dose limiting toxicity
Dose limiting toxicity
Dose limiting toxicity
Dose limiting toxicity

Secondary Outcome Measures

progression-free survival
progression-free survival
overall survival
overall survival

Full Information

First Posted
June 11, 2020
Last Updated
June 13, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04432402
Brief Title
Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Official Title
Efficacy and Safety of Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
R-Gemox, Lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide in Combination With R-GemOx
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Rituximab, Gemcitabine, oxaliplatin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
Maximum tolerated dose
Time Frame
at the end of the first cycle of R2-GemOx (each cycle is 14 days)
Title
Dose limiting toxicity
Description
Dose limiting toxicity
Time Frame
28 days
Title
Dose limiting toxicity
Description
Dose limiting toxicity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
progression-free survival
Description
progression-free survival
Time Frame
2 years
Title
overall survival
Description
overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 In any conditions which investigator considered ineligible for this study. Histologic transformation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Wang, M.D
Phone
+862568136034
Email
lilyw7878@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Xu, M.D., Ph.D
Phone
+862568136034
Email
xuwei0484@jsph.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xu, M.D., Ph.D
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang, M.D., Ph.D
Phone
86 25 68306034
Email
lilyw7878@163.com
First Name & Middle Initial & Last Name & Degree
Wei Xu, M.D., Ph.D
Phone
86 25 68306034
Email
xuwei10000@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs