R2 in the Treatment of Follicular Lymphoma

NCT ID: NCT03715309

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

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-11-01

Brief Summary

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Lenalidomide Based Immunotherapy in the Treatment of FL

Detailed Description

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Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma

Conditions

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Follicular Lymphoma

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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Revlimd

Group Type EXPERIMENTAL

Revlimid

Intervention Type DRUG

Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0

Interventions

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Revlimid

Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0

Intervention Type DRUG

Other Intervention Names

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lenalidomide

Eligibility Criteria

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Inclusion Criteria

Patients diagnose as de novo or relapse refractory FL grade 1-3A .

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

Role: CONTACT

+86 64370045 ext. 610707

Facility Contacts

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Zhong Zheng

Role: primary

64370045

Other Identifiers

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RJ-R2

Identifier Type: -

Identifier Source: org_study_id

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