A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND

MorphoSys AG1 site in 1 country66 target enrollmentDecember 11, 2019

ConditionsDiffuse Large B-cell Lymphoma

InterventionsTafasitamab Tafasitamab plus lenalidomide

DrugsTafasitamab Tafasitamab plus lenalidomide

Overview

Phase: Phase 1
Intervention: Tafasitamab
Conditions: Diffuse Large B-cell Lymphoma
Sponsor: MorphoSys AG
Enrollment: 66
Locations: 1
Primary Endpoint: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

Registry

clinicaltrials.gov

Start Date

December 11, 2019

End Date

August 10, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MorphoSys AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \>18 years
•Histologically confirmed diagnosis of DLBCL, not otherwise specified (NOS)
•Tumor tissue for retrospective central pathology review and correlative studies must be provided.
•At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
•International Prognostic Index (IPI) status of 2 to 5
•Appropriate candidate for R-CHOP
•Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
•Adequate hematologic, liver and renal function
•Females of childbearing potential (FCBP) must:

Exclusion Criteria

•Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
•Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
•History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
•History of prior non-hematologic malignancy except for the following:
•Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
•Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
•Adequately treated carcinoma in situ without current evidence of disease
•History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
•Patients with:
•positive test results for active hepatitis B and C

Arms & Interventions

Arm A

Tafasitamab in addition to R-CHOP

Intervention: Tafasitamab

Arm B

Tafasitamab plus lenalidomide in addition to R-CHOP

Intervention: Tafasitamab plus lenalidomide

Outcomes

Primary Outcomes

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

Time Frame: 6 months approximately

Secondary Outcomes

Anti-tafasitamab Antibodies Formation(12 months approximately)
Objective Response Rate (ORR) at the End of Treatment (EOT)(6 months approximately)
Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment(6 months approximately)
Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period(18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events)
Best Objective Response Rate (ORR) Until the End of Study (EOS)(24 months approximately)
Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study(24 months approximately)
Progression-free Survival (PFS) at 12 and 24 Months(24 months approximately)
Event-free Survival (EFS) at 12 and 24 Months(24 months approximately)
Time to Next Anti-lymphoma Treatment (TTNT)(24 months approximately)
Overall Survival at 12 and 24 Months(24 months approximately)