Follicular and Marginal Zone Lymphoma
Conditions
Interventions
Participants will be treated with the study drug combination for up to 1 year,
in 12 cycles of 28 days length. Participants will be divided into two treatment
groups:
Treatment Group A:
• Tafasitam
375 mg/m2 IV), 28-day cycle
- Cycle 1: Days 1, 8, 15, and 22
- Cycles 2 to 5: Day 1
• Lenalidomide (including generics
20 mg PO once daily), 28-day cycle
- Cycles 1 to 2: Days 1 to 21
Treatment Group B:
• Tafasitamab placebo (0.9% saline solution) IV, 28-day cycle
- Cycles 1 to 3: Days 1, 8, 15, and 22
- Cycles 4 to
20 mg PO once daily), 28-day cycle
- Cycles 1 to 12: Days 1 to 21
Sponsors
Incyte Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 as assessed locally; expression of CD19+ and CD20+ on lymphoma cells must be documented for all participants, FL and MZL, prior to randomization. - 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 (a participant in remission [in CR or PR] after the last prior treatment line would not be eligible): a. Relapsed lymphoma: relapsed after initial response of complete response (CR) to prior therapy. b. 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. c. Progressive lymphoma: PD after initial response of PR or stable disease (SD) to prior therapy. - Willingness to avoid pregnancy or fathering children
Exclusion criteria
Exclusion criteria: - Women who are pregnant or breastfeeding. - History of or current 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. - Taking a live vaccin during the 28 days prior to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) by investigator (INV) assessment in the FL population, using Lugano criteria (Cheson et al 2014). | — |
Secondary
| Measure | Time frame |
|---|---|
| • PFS by INV assessment in the overall population (FL and MZL populations) • PET-CR rate at EOT (90 days after last treatment) by INV in the FL population • OS in the FL population | — |
Countries
Netherlands
Outcome results
None listed