Phase 1
Completed N=66
Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL
Source: ClinicalTrials.gov NCT04134936 ↗Enrolled (actual)
66
Serious AEs
47.0%
Results posted
Oct 2024
Primary outcomePrimary: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) — 33; 33; 31; 32 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) |
33; 33; 31; 32; 9; 5 | — |
| SECONDARY Objective Response Rate (ORR) at the End of Treatment (EOT) |
25; 27 | — |
| SECONDARY Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment |
24; 22 | — |
| SECONDARY Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period |
26; 26; 9; 13; 9; 7 | — |
| SECONDARY Best Objective Response Rate (ORR) Until the End of Study (EOS) |
30; 31 | — |
| SECONDARY Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study |
28; 23 | — |
| SECONDARY Progression-free Survival (PFS) at 12 and 24 Months |
83.1; 76.8; 72.7; 76.8 | — |
| SECONDARY Event-free Survival (EFS) at 12 and 24 Months |
77.4; 68.0; 67.7; 68.0 | — |
| SECONDARY Time to Next Anti-lymphoma Treatment (TTNT) |
77.4; 71.9; 71.0; 68.8 | — |
| SECONDARY Overall Survival at 12 and 24 Months |
90.3; 93.8; 90.3; 93.8 | — |
| SECONDARY Anti-tafasitamab Antibodies Formation |
1; 0; 30; 32; 1; 0 | — |
Eligibility Criteria
Major 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
Major 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
Data sourced from ClinicalTrials.gov (NCT04134936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.