Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
- Conditions
- Large B-cell Lymphoma
- Registration Number
- NCT06045247
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Patients must meet the following criteria for study entry:<br><br> - Age =18 years<br><br> - Histologically diagnosed<br><br> - Diffuse large B-cell lymphoma, not otherwise specified (NOS) or<br><br> - High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or<br><br> - T cell/histiocyte-rich large B-cell lymphoma<br><br> - Have no prior systemic treatment for current lymphoma<br><br> - Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the<br> following:<br><br> - Age =80<br><br> - Unfit/frail by simplified geriatric assessment4<br><br> - The link to calculate simplified geriatric assessment<br> https://redcap.filinf.it/surveys/?s=89AFXML8AK Criteria Fit Unfit Frail ADL = 5 < 5<br> 6 < 6 IADL = 6 < 6 8 < 8 CIRS-G 0 score = 3-4<br><br> = 8 score = 2 = 1 score = 3-4 8 score = 2 0 score = 3-4 < 5 score = 2 = 1 score =<br> 3-4<br><br> = 5 score = 2 Age <80 < 80 = 80 = 80 Abbreviations: ADL, activities of daily living;<br> IADL, instrumental ADL; CIRS-G, Cumulative Illness Rating Scale for Geriatrics<br><br> - Ejection fraction (EF) <50% but =30%<br><br> - Needs to be asymptomatic or minimally symptomatic, New York Heart Association (NYHA)<br> class 1 or 2<br><br> - Previous cardiotoxic cancer treatment with anthracycline<br><br> - Stage II bulky (>7cm), III or IV disease<br><br> - Performance status =2 on the ECOG scale (PS =3 if attributed to lymphoma and<br> improves to =2 by pre-phase treatment prior to enrollment)<br><br> - Bi-dimensionally measurable disease, with at least one nodal lesion = 1.5 cm or one<br> extra-nodal lesion > 1 cm in longest diameter by CT, PET/CT, and/or MRI<br><br> - Patients must have adequate organ and marrow function as defined below:<br><br> - Absolute neutrophil count (ANC) =1.0 × 109/L*<br><br> --Growth factor permitted during screening<br><br> - Platelet count =75 × 109/L<br><br> - Total bilirubin = 3 ULN, unless consistent with Gilbert's (ratio between total and<br> direct bilirubin > 5)<br><br> - AST and ALT = 3x upper limit of normal (ULN)<br><br> - Alkaline phosphatase < 2.5 ULN<br><br> - Creatinine clearance >45 ml/min calculated by modified Cockcroft-Gault formula<br><br> - All subjects must<br><br> - Agree to refrain from donating blood while on study treatment, during dose<br> interruptions and for at least 12 months following the last dose of study treatment.<br><br> - Sign an informed consent document indicating that they understand the purpose of and<br> procedures required for the study, including biomarkers, and are willing to<br> participate in the study.<br><br>The investigator is responsible for: ensuring that the patient understands the potential<br>risks and benefits of participating in the study; ensuring that informed consent is given<br>by each patient, this includes obtaining the appropriate signatures and dates on the<br>informed consent document prior to the performance of any study procedures and prior to<br>the administration of study treatment; answering any questions the patient may have<br>throughout the study and sharing in a timely manner any new information that may be<br>relevant to the patient's willingness to continue his or her participant in the trial.<br>Subjects will undergo a brief physical exam including a brief exam to determine cognitive<br>review. No one without capacity to personally consent will be enrolled. Patients have<br>medical decision-making capacity if they can demonstrate understanding of the situation,<br>appreciation of the consequences of their decision, and reasoning in their thought<br>process, and if they can communicate their wishes.<br><br>A determination of lack of decision-making capacity shall be made after an appropriate<br>medical evaluation that concludes there is little or no likelihood that the participant<br>will regain decision-making capacity in a reasonable period of time.<br><br> - Females must agree to abstain from breastfeeding during study participation and for<br> at least 12 months after epcoritamab discontinuation.<br><br> - Females of childbearing potential (FCBP§) must:<br><br> - Have one negative pregnancy tests via serum or urine prior to starting study<br> therapy. She must agree to ongoing pregnancy testing during the course of the study,<br> prior to day 1 of each cycle, and after end of study therapy. This applies even if<br> the subject practices true abstinence from heterosexual contact.<br><br> - Not engaging in sexual activity for the total duration of the trial and the drug<br> washout period is an acceptable practice. Otherwise, she must agree to use, and be<br> able to comply with two forms of contraception: one highly effective, and one<br> additional effective (barrier) measure of contraception without interruption 28 days<br> prior to starting epcoritamab, during the study treatment (including dose<br> interruptions), and for at least 12 months after the last dose of epcoritamab.<br><br> - Male subjects must:<br><br> - A male subject who is sexually active with a female with reproductive potential must<br> agree to use a barrier method of birth control, eg, either condom with spermicidal<br> foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or<br> cervical/vault caps) with spermicidal foam/gel/film/cream/ suppository (including<br> dose interruptions), even if they have undergone a successful vasectomy, from the<br> time of signing consent and for at least 12 months after the last dose of<br> epcoritamab. A male subject must agree not to donate sperm or semen, while taking<br> epcoritamab, during breaks (dose interruptions), and for at least 12 months after<br> the last dose of epcoritamab.<br><br>Exclusion Criteria<br><br>Subjects will be ineligible for this study if they meet any of following criteria:<br><br> - Known central nervous system lymphoma or leptomeningeal disease<br><br> - Suspicious case with symptoms should be evaluated with brain MRI with or without Any<br> prior history of other malignancy besides B-NHL, unless the patient has been free of<br> disease for = 3 years and felt to be at low risk for recurrence by the treating<br> physician, except:<br><br> - Adequately treated localized skin cancer without evidence of disease.<br><br> - Adequately treated cervical carcinoma in situ without evidence of disease.<br><br> - Any life-threatening illness, medical condition, or organ system dysfunction which,<br> in the investigator's opinion, could compromise the subject's safety, or put the<br> study outcomes at undue risk.<br><br> - Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or<br> active Hepatitis B Virus infection, or any uncontrolled active significant<br> infection, including suspected or confirmed JC virus infection and SARS-CoV2<br><br> - Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation<br> prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who<br> are hepatitis B core antibody (anti-HBc) positive and who are surface antigen<br> negative will need to have a negative polymerase chain reaction (PCR). Those who are<br> hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be<br> excluded. Subjects who are hepatitis C antibody positive will need to have a<br> negative PCR result. Those who are hepatitis C PCR positive will be excluded.<br> Subjects with a history of Hepatitis C who received antiviral treatment are eligible<br> as long as PCR is negative.<br><br> - History of severe all
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
- Secondary Outcome Measures
Name Time Method