TAFASITAMAB for Follicular lymphoma | Marginal zone lymphoma

Stratification factors

• disease (FL versus MZL)

Inclusion criteria

• {"criterion_text":"- 1. 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"}
• {"criterion_text":"- 2. 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."}
• {"criterion_text":"- 3. Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy a. Relapsed lymphoma: relapsed after initial response of CR or PR ≥ 6 months after prior therapy. b. Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or PR that lasted less than 6 months. c. Progressive lymphoma: PD after initial response of SD to prior therapy. Please refer to section 5.1 of the protocol for the full list of inclusion criteria."}

Exclusion criteria

• {"criterion_text":"- 1. Women who are pregnant or breastfeeding."}
• {"criterion_text":"- 2. History of or current histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment."}
• {"criterion_text":"- 3. History of radiation therapy to ≥ 25% of the BM for other diseases."}
• {"criterion_text":"- 4. Active systemic infection."}
• {"criterion_text":"- 5. Participants in a severely immunocompromised state."}
• {"criterion_text":"- 6. Known CNS lymphoma involvement. Please refer to section 5.2 of the protocol for the full list of exclusion criteria."}

Primary endpoints

• {"endpoint_text":"- PFS by investigator (INV) assessment in the FL population, using Lugano 2014 criteria (Cheson et al 2014). PFS is defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS assessed by investigator (INV) using Lugano 2014 criteria; PFS defined as time from randomization to first documented disease progression or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- * PFS by INV assessment in the overall population (FL and MZL populations). * PET-CR rate by INV in the FDG-avid FL population, defined as a complete metabolic response at any time after start of treatment. *OS in the FL population.","definition_or_measurement_approach":"PFS by INV in overall population; PET-CR rate by INV in FDG-avid FL defined as complete metabolic response at any time after treatment start; OS = overall survival in FL population."}

Methods

• eNewsletter content — electronic newsletter materials prepared for recruitment (documents titled 'eNewsletter content'). Target audience: patients and HCPs as appropriate; country-specific versions available.
• Social media ads — recruitment via social media advertising (documents titled 'social media ads'). Target audience: potential patient population/public; country-specific versions available.
• Web banner ads — online banner advertisements (documents titled 'web banner ad' / 'Web banner'). Target audience: general public/patients; country-specific versions available.
• Patient brochure and Patient FAQ brochure — printed/digital brochures for patients explaining the study (documents titled 'patient brochure', 'patient FAQ brochure'). Target audience: patients; country-specific translations available.
• PAG study fact sheet / PAG to patient letter — materials for Patient Advocacy Groups (PAG) and letters routed via PAGs to patients. Target audience: patient advocacy groups and patients; country-specific versions available.
• Dr-to-Dr letters and GP letters — recruitment outreach to physicians/GPs via letters to inform about the study (documents titled 'dr to dr letter', 'GP Letter'). Target audience: referring physicians and site clinicians; country-specific versions available.
• Chart review checklist — site-based retrospective chart review tools to identify eligible patients (document titled 'chart review checklist'). Target audience: site clinicians/site staff.
• Site staff welcome letter / site staff materials / toolkit sheet — materials to engage and inform site staff to support recruitment (documents titled 'site staff welcome letter', 'toolkit sheet'). Target audience: site staff and study coordinators.
• Trial card / trial card pocket size / visit reminder card — pocket cards and reminder cards for participants (documents titled 'trial card', 'Visit Reminder Card'). Target audience: enrolled participants.
• Dosing diary Lenalidomide / Participant diaries — tools for participants to record dosing (document titled 'Dosing Diary Lenalidomide'). Target audience: participants to support adherence and safety reporting.
• Patient Emergency Card / Participant emergency card — cards for participants for emergency contact and study ID (documents titled 'Patient Emergency Card'). Target audience: participants.

Primary sponsor

Full Name

Incyte Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Hellas Single Member S.A.

Responsibilities

Operational/sponsor support (sponsorDuties codes: [1,12,5])

Name

Syneos Health Netherlands B.V.

Responsibilities

Operational/sponsor support (sponsorDuties codes: [1,12,2,5,6,7])

Name

Icon Development Solutions LLC

Responsibilities

ADA samples analysis / operational support

Name

Bioclinica Inc.

Responsibilities

Medical image analysis/review

Name

IQVIA Laboratories Limited

Responsibilities

Clinical trial information / laboratory support (sponsorDuties code: 4)

Third parties

• {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: [1, 12, 5]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc. (San Diego)","duties_or_roles":"Lymphoid NGS testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc. (Houston)","duties_or_roles":"Extract and IgH clonality/MRD NGS testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc. (Aliso Viejo)","duties_or_roles":"MRD (minimal residual disease) analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Universitaetsklinikum Schleswig-Holstein","duties_or_roles":"Ship to Address (For Aliq B)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"ADA samples analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: [1,12,2,5,6,7]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Inivata Limited","duties_or_roles":"Cryopreservation","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patients' recruitment support","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Eurofins Adme Bioanalyses","duties_or_roles":"Pharmacokinetics","organisation_type":"Pharmaceutical company"}