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Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

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

NCT03367143•Ruijin Hospital

Summary

This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.

Eligibility

Age

16 - 75 years

Sex

ALL

Healthy Volunteers

•1. 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.
•2. No history of stem cell transplantation.
•3. Age between 16-75.
•4. ECOG\<3.
•5. At least 1 measurable tumor mass.
•6. Minimum life expectancy of 3 months.
•7. Written informed consent.
•8. No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
•9. 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.

•1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
•2. Clinically significant active infection.
•3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
•4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
•5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
•6. Patients who are pregnant or breast-feeding.
•7. HIV infection.

Locations (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 1, 2016

Primary Completion Date

December 1, 2020

Completion Date

December 1, 2020

Last Updated

March 11, 2020

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-Cell Lymphoma Refractory

Interventions

Lenalidomide

DRUG

Ifosfamide

DRUG

Carboplatin

DRUG

Etoposide

DRUG