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

NCT06045247 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0031NCI-2023-07174
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion: an average of 1 year

Study Arms (1)

R-miniCVP+ Epcoritamab

EXPERIMENTAL

Starting on Day 1 of Cycle 2, you will also receive epcoritamab 1 time each week (Days 1, 8, 15, and 22 of each cycle). Epcoritamab is given as an injection under your skin, after you complete your dose of R-miniCVP. You may receive up to 6 cycles of R-miniCVP (Cycles 1-6) and up to 11 cycles of epcoritamab (Cycles 2-12), depending on how the disease responds to treatment.

Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Epcoritamab

Interventions

Prednisone DRUG

Given by IV (vein)

R-miniCVP+ Epcoritamab

Rituximab DRUG

Given by IV (vein)

R-miniCVP+ Epcoritamab

Cyclophosphamide DRUG

Given by IV (vein)

R-miniCVP+ Epcoritamab

Vincristine DRUG

Given by IV (vein)

R-miniCVP+ Epcoritamab

Epcoritamab DRUG

Given under the skin

R-miniCVP+ Epcoritamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects will be ineligible for this study if they meet any of following criteria:
• Known central nervous system lymphoma or leptomeningeal disease
• Suspicious case with symptoms should be evaluated with brain MRI with or without Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:
• Adequately treated localized skin cancer without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.
• Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2
• Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
• History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.
• History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \>10mg/day of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.
• Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, 3rd degree block, 12-lead ECG showing a baseline QTcF \>470 msec.
• History of stroke, seizure disorder or patients requiring antiepileptic therapy or intracranial hemorrhage within 6 months prior to study entry.
• Patients with more than mild pericardial effusion confirmed by ECHO.
• Lactating or pregnant subjects

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Prednisone; Rituximab; Cyclophosphamide; Vincristine

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Dai Chihara, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dai Chihara, MD

CONTACT

713-792-2860; dchihara@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)