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Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma

NCT05338879 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 247

Last updated 2023-10-18

No results posted yet for this study

Summary

Primary Objective:

To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review.

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting:

1. Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation
2. Complete response (CR) rate according to the Lugano classification and as assessed by:

* Independent central review, and
* Treating physician evaluation
3. Progression-free survival (PFS) according to the Lugano classification and as assessed by:

* Independent central review, and
* Treating physician evaluation
4. Overall survival (OS)
5. Duration of response (DOR) according to the Lugano classification and as assessed by:

* Independent central review, and
* Treating physician evaluation
6. Disease control rate (DCR) according to the Lugano classification and as assessed by:

* Independent central review, and
* Treating physician evaluation
7. Time to next treatment (TTNT)
8. Histological transformation (HT)

Conditions

  • Relapsed/Refractory Follicular Lymphoma

Interventions

OTHER

Non-Interventional

No study treatment will be administered on this study.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2023-10-05
Completion
2023-10-05

Countries

  • Austria
  • France
  • Germany
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338879 on ClinicalTrials.gov