Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

NCT ID: NCT03367143

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Conditions

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Diffuse Large B-Cell Lymphoma Refractory

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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L-ICE

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

Group Type EXPERIMENTAL

Lenalidomide

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Interventions

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Lenalidomide

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weili Zhao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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L-ICE

Identifier Type: -

Identifier Source: org_study_id

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