A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma

JRCT ID: jRCT2021210065

Registered date:18/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Follicular Lymphoma, Marginal Zone Lymphoma
• Date of first enrollment: 08/03/2022
• Target sample size: 618
• Countries of recruitment: U.S.A,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,Ireland,Japan,Russian Federation,Japan,Sweden,Japan,Turkey,Japan,Ukraine,Japan
• Study type: Interventional

Intervention(s)

Arm A : tafasitamab + rituximab + lenalidomide
Tafasitamab (INCMOR00208, MOR00208) will be administered IV for 12 cycles.
Rituximab will be administered IV on cycles 1 - 5.
Lenalidomide will be administered PO for 12 cycles.

Arm B : placebo + rituximab + lenalidomide
Placebo will be administered IV for 12 cycles.
Rituximab will be administered IV on cycles 1 - 5.
Lenalidomide will be administered PO for 12 cycles.

Outcome(s)

• Primary Outcome: Progression Free Survival (PFS) in FL population

Secondary Outcome

1. Progression Free Survival (PFS) in FL and MZL populations
2. Complete Response in FL population
3. Minimal Residual Disease-negativity rate in FL and MZL population
4. Overall Survival in FL population
5. Complete Response in overall population
6. Overall Survival in overall population
7. Best Overall Response Rate in FL and overall population
8. Duration of Response in FL and overall population
9. Quality-of-Life Assessments in FL and overall populations
10. Safety: Number of participants with TEAE's

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- Willingness to avoid pregnancy or fathering children
- In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
- Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
- Documented relapsed, refractory, or PD after treatment with systemic therapy
- ECOG performance status of 0 to 2

Exclude criteria

- Women who are pregnant or breastfeeding.
- Any histology other than FL and MZL or clinical evidence of transformed lymphoma
- Prior non-hematologic malignancy
- Congestive heart failure
- HCV positivity, chronic HBV infection or history of HIV infection
- Active systemic infection
- CNS lymphoma involvement
- Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
- Prior use of lenalidomide in combination with rituximab

Related Information

• Primary Sponsor: Eiji Ueda
• Secondary ID(s): NCT04680052