Back to resultsLenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
Primary Purpose
Diffuse Large B-Cell Lymphoma Refractory
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lenalidomide
Ifosfamide
Carboplatin
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma Refractory
Eligibility Criteria
Inclusion Criteria:
- Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
- No history of stem cell transplantation.
- Age between 16-75.
- ECOG<3.
- At least 1 measurable tumor mass.
- Minimum life expectancy of 3 months.
- Written informed consent.
- No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
- No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.
Exclusion Criteria:
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- Patients who are pregnant or breast-feeding.
- HIV infection.
Sites / Locations
- Shanghai Ruijin Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
L-ICE
Arm Description
Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
Outcomes
Primary Outcome Measures
Complete response rate
Secondary Outcome Measures
Progression free survival rate
Overall survival rate
Overall response rate
Safety as assessed using CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03367143
Brief Title
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
Official Title
A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L-ICE
Arm Type
Experimental
Arm Description
Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Progression free survival rate
Time Frame
1 year
Title
Overall survival rate
Time Frame
1 year
Title
Overall response rate
Time Frame
12 weeks
Title
Safety as assessed using CTCAE v4.0
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
No history of stem cell transplantation.
Age between 16-75.
ECOG<3.
At least 1 measurable tumor mass.
Minimum life expectancy of 3 months.
Written informed consent.
No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.
Exclusion Criteria:
Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
Clinically significant active infection.
Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
Patients who are pregnant or breast-feeding.
HIV infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD, PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
We'll reach out to this number within 24 hrs