Status:
COMPLETED
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
Lead Sponsor:
MorphoSys AG
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, Doxorub...
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
December 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04134936
Start Date
December 11 2019
End Date
August 10 2022
Last Update
October 16 2024
Active Locations (70)
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1
MorphoSys Research Site
Tucson, Arizona, United States, 85711
2
MorphoSys Research Site
Anaheim, California, United States, 92801
3
MorphoSys Research Site
Duarte, California, United States, 91010
4
MorphoSys Research Site
Encinitas, California, United States, 92024