Lenalidomide Based Immunotherapy in the Treatment of DLBCL

NCT ID: NCT03715296

Last Updated: 2019-07-08

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-18

Study Completion Date

2020-09-15

Brief Summary

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This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients

Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lenalidomide 25mg

Lenalidomide 25mg/d PO d1-10 Plus Rituximab 375 mg/m2 IV d1, Cyclophosphamide 750mg/m2 IV d2, Doxorubicin 50mg/m2 IV d2, Vincristine 1.4 mg/m2 IV d2, Prednisone 60 mg/m2 PO d2-6 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5\*\[GFR(ml/min)+25\]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3,

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)

Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.

No history of stem cell transplantation.

Written informed consent.

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.
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

Locations

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Ruijin hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weili Zhao, MD, PhD

Role: CONTACT

64370045 ext. 610707

Zhong Zheng, MD

Role: CONTACT

64370045 ext. 610707

Facility Contacts

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Weili ZHAO, MD, PhD

Role: primary

86-21-64370045 ext. 610707

Shu CHENG, MD, PhD

Role: backup

86-21-64370045 ext. 665251

Other Identifiers

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NHL-007

Identifier Type: -

Identifier Source: org_study_id

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