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About
To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.
Full description
Primary Objectives:
--To determine the efficacy of epcoritamab in combination with R-miniCVP as determined by CR rate after six cycles of combination treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL.
Secondary Objectives
--To determine best overall response rate (ORR), duration of response, progression-free survival (PFS), overall survival (OS), and evaluation of safety of epcoritamab in combination with R-miniCVP as treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL.
Exploratory Objectives:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Patients must meet the following criteria for study entry:
Age ≥18 years
Histologically diagnosed
Diffuse large B-cell lymphoma, not otherwise specified (NOS) or
High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or
T cell/histiocyte-rich large B-cell lymphoma
Have no prior systemic treatment for current lymphoma
Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the following:
Age ≥80
Unfit/frail by simplified geriatric assessment4
The link to calculate simplified geriatric assessment https://redcap.filinf.it/surveys/?s=89AFXML8AK Criteria Fit Unfit Frail ADL ≥ 5 < 5 6 < 6 IADL ≥ 6 < 6 8 < 8 CIRS-G 0 score = 3-4
≤ 8 score = 2 ≥ 1 score = 3-4 8 score = 2 0 score = 3-4 < 5 score = 2 ≥ 1 score = 3-4
≥ 5 score = 2 Age <80 < 80 ≥ 80 ≥ 80 Abbreviations: ADL, activities of daily living; IADL, instrumental ADL; CIRS-G, Cumulative Illness Rating Scale for Geriatrics
Ejection fraction (EF) <50% but ≥30%
Needs to be asymptomatic or minimally symptomatic, New York Heart Association (NYHA) class 1 or 2
Previous cardiotoxic cancer treatment with anthracycline
Stage II bulky (>7cm), III or IV disease
Performance status ≤2 on the ECOG scale (PS ≤3 if attributed to lymphoma and improves to ≤2 by pre-phase treatment prior to enrollment)
Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion > 1 cm in longest diameter by CT, PET/CT, and/or MRI
Patients must have adequate organ and marrow function as defined below:
Absolute neutrophil count (ANC) ≥1.0 × 109/L*
--*Growth factor permitted during screening
Platelet count ≥75 × 109/L
Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin > 5)
AST and ALT ≤ 3x upper limit of normal (ULN)
Alkaline phosphatase < 2.5 ULN
Creatinine clearance >45 ml/min calculated by modified Cockcroft-Gault formula
All subjects must
Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment.
Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
The investigator is responsible for: ensuring that the patient understands the potential risks and benefits of participating in the study; ensuring that informed consent is given by each patient, this includes obtaining the appropriate signatures and dates on the informed consent document prior to the performance of any study procedures and prior to the administration of study treatment; answering any questions the patient may have throughout the study and sharing in a timely manner any new information that may be relevant to the patient's willingness to continue his or her participant in the trial. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review. No one without capacity to personally consent will be enrolled. Patients have medical decision-making capacity if they can demonstrate understanding of the situation, appreciation of the consequences of their decision, and reasoning in their thought process, and if they can communicate their wishes.
A determination of lack of decision-making capacity shall be made after an appropriate medical evaluation that concludes there is little or no likelihood that the participant will regain decision-making capacity in a reasonable period of time.
Exclusion Criteria
Subjects will be ineligible for this study if they meet any of following criteria:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Dai Chihara, MD
Data sourced from clinicaltrials.gov
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