How You Can Help
You may have patients with lymphoma who are seeking effective frontline treatments or are still seeking other therapies due to inadequate response to their current medications, which can be frustrating. Because treatment options are still limited, let your patients know that an alternative approach is participating in clinical research. The following lymphoma research studies are available:
The EPCORE NHL-5 Study is evaluating the safety and tolerability of a primary investigational drug in combination with other drugs for adults with non-Hodgkin lymphoma.
- Are at least 18 years old
- Have a diagnosis of one of the following:
- DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease at most recent representative tumor biopsy pathology report, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
- DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit")
Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible - Follicular lymphoma (FL) Grade 3b
- FL with histologically confirmed CD20+ Grade 1 to 3a FL and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy pathology report according to WHO 2016 classification
- Mantle cell lymphoma with histologically confirmed CD20+ disease at most recent representative tumor biopsy pathology report according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or PCR
- A report from the local laboratory is acceptable if available; if unavailable, a tumor block or slides must be sent to the central pathology laboratory for confirmation
- DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease at most recent representative tumor biopsy pathology report, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
This research study is evaluating the safety and efficacy of a drug for a specific use that is currently not approved by regulatory health authorities.
For additional information:
The EPCORE PEDS-1 Study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of an investigational drug in children, teens, and young adults with relapsed or refractory aggressive mature B-cell neoplasms.
- Were at least 1 and under 18 years old at the time of primary diagnosis
- Patients up to 25 years old with a diagnosis of relapsed or refractory Burkitt’s or Burkitt-like lymphoma/leukemia are also eligible
- Have a histologically confirmed CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008:
- DLBCL – de novo or transformed
- Burkitt's or Burkitt-like lymphoma/leukemia
- Other aggressive mature B-cell lymphomas
- Patients with relapsed or primary refractory disease (as above) meeting any of the following criteria:
- Progressive disease at any time during or after second-line chemoimmunotherapy (CIT)
- Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT
- Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT
- CR after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy
- Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT
- Cell therapy (allogeneic or autologous transplant or CAR-T therapy) received as consolidation, but CR was not obtained or maintained
This investigational drug being studied in patients with mature B-cell NHL is under clinical development and is not approved for use by regulatory health authorities. Safety and efficacy are under evaluation.
For additional information:
The EPCORE NHL-6 Study is evaluating the safety and efficacy of an investigational drug for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and R/R classic follicular lymphoma (cFL) (previously follicular lymphoma grade 1-3a).
- Are adult males or females, at least 18 years old, with a life expectancy > 3 months on standard of care (SOC) treatment.
- Meet the following disease activity criteria:
- R/R DLBCL:
- Have documented CD20+ mature B-cell neoplasm according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours based on representative and most recent pathology report
- Diffuse large B-cell lymphoma, NOS (de novo or transformed from FL or Marginal Zone Lymphoma [MZL])
- Can include patients with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL-2 and/or BCL-6 translocations)
Note: Other double-/triple-hit lymphomas are not eligible
- Can include patients with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL-2 and/or BCL-6 translocations)
- Diffuse large B-cell lymphoma, NOS (de novo or transformed from FL or Marginal Zone Lymphoma [MZL])
- Have R/R disease and were previously treated with at least 1 prior systemic antineoplastic therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy
Note: Relapsed disease is defined as disease that previously responded to therapy but progressed ≥ 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy) - Have either failed prior autologous hematopoietic stem cell transplantation (HSCT), or ineligible for autologous HSCT due to age, Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities and/or insufficient response to prior treatment
- Have documented CD20+ mature B-cell neoplasm according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours based on representative and most recent pathology report
- R/R cFL:
- Have documented CD20+ mature B-cell neoplasm according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours based on representative pathology report
- Classic (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation
- Have R/R disease and previously treated with at least 2 prior lines of systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy
- Have been previously treated with an alkylating agent or lenalidomide
- Have R/R to the last prior line therapy. Previous lymphoma therapy is defined as 1 of the following: At least 2 months of single-agent therapy, at least 2 consecutive cycles of combination therapy, autologous HSCT, immunomodulatory therapy, or radioimmunotherapy
- Have documented CD20+ mature B-cell neoplasm according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours based on representative pathology report
- R/R DLBCL:
- Participant has no uncontrolled Human Immunodeficiency Virus (HIV) infection.
- HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed.
- CD4 count must be ≥ 350 cells/µl and serum HIV viral load < lower limit of detection for at least 1 year prior to enrollment
This study is investigating the use of epcoritamab in the outpatient setting, currently not approved by the FDA. Safety and efficacy of this investigational use is under evaluation.
For additional information:
The EPCORE FL-1 Study is evaluating the safety and efficacy of an investigational drug in combination with standard-of-care drugs for adults with relapsed or refractory (R/R) follicular lymphoma.
- Are at least 18 years old
- Have histologically confirmed Grade 1 to 3a FL, Stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report
- Have R/R disease to at least 1 prior regimen that contained an anti-CD20 monoclonal antibody in combination with (an)other anti-lymphoma agent(s) (those who received only prior anti-CD20 monoclonal antibody monotherapy and/or radiation therapy are not eligible)
Note: Relapsed disease is defined as disease that previously responded to therapy but progressed ≥ 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy)
This investigational drug being studied in FL patients is under clinical development and is not approved for use by regulatory health authorities. Safety and efficacy are under evaluation.
For additional information:
The EPCORE DLBCL-2 Study is evaluating the safety and efficacy of an investigational drug in combination with standard-of-care drugs for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
- Are at least 18 years old and no more than 79 years old, with a life expectancy of ≥ 12 months
- Have newly diagnosed, histologically confirmed CD20+ DLBCL (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
- DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology
- T-cell/histiocyte-rich large B-cell lymphoma
- Epstein-Barr virus–positive DLBCL, NOS
- Follicular lymphoma Grade 3b
- Have no history of prior systemic anti-lymphoma therapy for DLBCL (including any definitive radiotherapy with curative intent)
- If histologically transformed from follicular lymphoma (FL), must not have previously been treated with > 1 lines of therapy for FL and must not have had an anthracycline-containing regimen or a CD3-CD20 bispecific antibody
This investigational drug being studied in DLBCL patients is under clinical development and is not approved for use by regulatory health authorities. Safety and efficacy are under evaluation.
For additional information:
The EPCORE FL-2 Study is evaluating the safety and efficacy of an investigational drug in combination with a chemotherapy-free regimen compared to the standard-of-care chemoimmunotherapy for adults with previously untreated follicular lymphoma (FL).
- Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report
- Have Ann Arbor stage II, III, or IV disease
- Have no history of prior systemic anti-lymphoma therapy for FL (including any definitive radiotherapy with curative intent)
This investigational drug being studied in FL patients is under clinical development and is not approved for use by regulatory health authorities. Safety and efficacy are under evaluation.
For additional information:
The EPCORE DLBCL-4 Study is evaluating the safety and efficacy of a study drug in combination with another antineoplastic agent compared to standard-of-care treatment for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
- Are 18 years of age or older
- Have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drugs
- Have histologically confirmed CD20+ DLBCL documented in their most recent representative pathology report
- Have R/R DLBCL and have received at least 1 prior systemic anti-lymphoma therapy (an anti-CD20 therapy must have been included in a prior line)
- Have relapsed/progressed after, or are ineligible for or unable to receive, CAR-T therapy or autologous stem cell transplant
- Have at least 1 target lesion defined as a measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI and 18F-FDG PET-positive on PET-CT scan
This research study is evaluating the safety and efficacy of an approved drug for a specific investigational use that is currently not approved by regulatory health authorities.
For additional information:
