NCT05846763

Brief Summary

This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Nov 2022May 2028

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Expected
Last Updated

May 23, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

April 27, 2023

Last Update Submit

May 21, 2023

Conditions

Follicular Lymphoma

Keywords

follicular lymphomaObinutuzumabLenalidomidereal-world

Outcome Measures

Primary Outcomes (1)

  • overall response rate（ORR）

    Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.

    24 weeks

Secondary Outcomes (6)

  • 2-year Progression free survival（PFS24）

    Up to 4.5 years

  • 2-year Event-free survival（EFS24）

    Up to 4.5 years

  • Complete response (CR)

    2.5 years

  • Duration of response (DoR)

    Up to 4.5 years

  • Overall survival (OS)

    Up to 4.5 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will include the population of patients with relapsed and refractory follicular lymphoma who are planned to receive the combination of obinutuzumab and Lenalidomide in 9 centers (including 8 sub-centers outside of the Institute of Hematology \& Blood Diseases Hospital )

You may not qualify if:

  • Patients currently participating or planning to participate in any interventional clinical trial
  • Any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shuhua Yi, Dr

    Institute of Hematology & Blood Diseases Hospital, Chinese

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shuhua Yi, Dr

CONTACT

86-22-23909106yishuhua@ihcams.ac.cn

Lugui Qiu, Dr

CONTACT

86-22-23909172qiulg@ihcams.ac.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 6, 2023

Study Start

November 1, 2022

Primary Completion

May 31, 2026

Study Completion (Estimated)

May 31, 2028

Last Updated

May 23, 2023

Record last verified: 2023-04

Locations

CN(1)