NCT03715309

Brief Summary

Lenalidomide Based Immunotherapy in the Treatment of FL

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

October 19, 2018

Last Update Submit

July 4, 2019

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • CR

    Complete response rate

    12 weeks

Secondary Outcomes (3)

  • PFS

    1 year

  • OS

    1 year

  • ORR

    12 weeks

Study Arms (1)

Revlimd

EXPERIMENTAL
Drug: Revlimid

Interventions

RevlimidDRUG

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

Also known as: lenalidomide
Revlimd

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnose as de novo or relapse refractory FL grade 1-3A .
  • No history of stem cell transplantation.
  • Written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Weili Zhao

CONTACT

+86 64370045Zhao.weili@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 23, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

CN(1)