Status:
UNKNOWN
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
Lead Sponsor:
Ruijin Hospital
Conditions:
Diffuse Large B-Cell Lymphoma Refractory
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03367143
Start Date
December 1 2016
End Date
December 1 2020
Last Update
March 11 2020
Active Locations (1)
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1
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025