NCT04134936CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- MorphoSys AG
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •not be pregnant
- •refrain from breast feeding and donating oocyte
- •agree to ongoing pregnancy testing
- •commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
- •Males must:
- •use an effective barrier method of contraception if sexually active with FCBP
- •refrain from donating sperm
- •In the opinion of investigator, the patient must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
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
- •known seropositive for or history of active viral infection with human immunodeficiency virus (HIV)
- •known active bacterial, viral, fungal, mycobacterial, or other infection at screening
- •known central nervous system (CNS) lymphoma involvement
- •history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator opinion preclude participation in the study
Arms & Interventions
Arm A
Experimental
Tafasitamab in addition to R-CHOP
Intervention: Tafasitamab (Drug)
Arm B
Experimental
Tafasitamab plus lenalidomide in addition to R-CHOP
Intervention: Tafasitamab plus lenalidomide (Drug)
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)
Investigators
Study Sites (1)
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