A Phase 3 study of Tafasitamab plus Lenalidomide in addition to Rituximab, versus Lenalidomide plus Rituximab in patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Phase 1

• Conditions: follicular lymphoma (FL) and marginal zone lymphoma (MZL); MedDRA version: 24.0Level: LLTClassification code 10080213Term: In situ follicular lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004407-13-IT
• Lead Sponsor: INCYTE CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

* Male and female participants at least 18 years of age who have a histologically confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL of the MALT.

* Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance.

* Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy:
- Relapsed lymphoma: relapsed after initial response of complete response (CR) to prior therapy.
- Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or partial response (PR) that lasted less than 6 months before lymphoma progression.
- Progressive lymphoma: PD after initial response of PR or stable disease (SD) to prior therapy.

* Willingness to avoid pregnancy or fathering children
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 352
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 266

Exclusion Criteria

* Women who are pregnant or breastfeeding.
* Any histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment.
* History of radiation therapy to = 25% of the BM for other diseases.
* Active systemic infection.
* Participants in a severely immunocompromised state.
* Known CNS lymphoma involvement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified