Phase Ib/II, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
Study Identifier:
M22-132
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Recruiting
Considering participating in a START clinical trial?
Study Summary
To evaluate the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. To evaluate the safety and tolerability of a new combination therapy of epcolitamab and a new antitumor drug in patients with B-cell NHL. Preliminary biomarker analysis showed pharmacodynamic profiles consistent with the mechanism of action of epcoritamab. These include predictable cytokine peaks immediately after the first full dose (IFN-gamma, IL-2, and IL-6) with a rapid and sustained depletion of peripheral B cells. To evaluate the safety, tolerability, and antitumor activity of epcor + pola-R-CHP in pts with newly diagnosed DLBCL. The following biomarker assessments were performed as per-protocol predefined timepoints: CD20/PAX5 expression in baseline tumor samples assessed by immunohistochemistry (IHC), peripheral blood (PB) immune phenotypes assessed by flow cytometry, and plasma cytokines analyzed by multiplex immunoassay. Plasma ctDNA levels were quantified at various timepoints during treatment using the Avenio NHL CAPP-Seq assay (Roche); MRD negativity was defined as <1 mutant molecule per ml (MMPM). Best overall response (BOR) was assessed by an independent review committee using Lugano criteria Key endpoints included dose-limiting toxicities (DLTs), investigator-assessed response (overall response rate [ORR] and complete response [CR] rate), duration of response (DOR), time to response, and safety. To report updated safety, tolerability, and antitumor activity data of epcor + pola-R-CHP in pts with newly diagnosed DLBCL.
To characterize the safety and toxicity profile of epcoritamab administered in combination with antineoplastic agents in subjects with B-cell non-Hodgkin's lymphoma (NHL). - To determine the recommended dose for further investigation of epcoritamab in combination with antineoplastic drugs in subjects with B-cell NHL. - To evaluate the anti-NHL activity of epcoritamab administered in combination with antineoplastic agents in subjects with B-cell NHL. - To characterize the pharmacokinetics of epcoritamab administered in combination with antineoplastic drugs in subjects with B-cell NHL.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Diagnosis of: -- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, 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. OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy 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, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR). Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arms 6, 7, and 8 where ECOG performance status must be 0-1. Must have 1 or more measurable disease sites: A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI). Adult male or female, at least 18 years old (Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to 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 World Health Organization (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 - FL Grade 3B OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR MCL with histologically confirmed CD20+ disease at most recent representative tumor biopsy 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 Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2, except for Arms 6, 7 and 8where ECOG performance status must be 0-1 Subject must have 1 or more measurable disease sites: A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND - At least 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI
- 1Subject or his/her legally authorized representative must voluntarily sign and date an independent Ethics Committee (IEC)/institutional review board (IRB)-approved informed consent form prior to initiation of any screening or study-specific procedures.2Adult male or female, 18 years of age or older.3Laboratory examination values that meet the following criteria as described in the study protocol during the screening period prior to the first dose of study drug.4Subject is willing and able to comply with the procedures required in this study protocol.5Subjects must be able to tolerate subcutaneous injections.6Subjects must have adequate fresh or paraffin-embedded tissue at screening.7- (Groups 1, 2, 3, and 4) Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with CD20 + according to WHO 2016 classification (primary or histologically transformed from follicular lymphoma or marginal zone lymphoma), containing the following types and documented in the pathology report: -- DLBCL, NOS. -- High-grade B-cell lymphoma ("double hit" or "triple hit") with MYC and BCL-2 and/or BCL-6 translocation ("double hit" or "triple hit") according to WHO 2016 criteria Note: High grade B-cell lymphoma NOS or other double hit/triple hit lymphoma (histologically inconsistent with DLBCL) are not eligible. -- Follicular lymphoma (FL) - grade 3B. OR - (Group 5) Histologically confirmed grade 1-3a FL of CD20+ according to WHO 2016 classification with no histologic evidence of invasive lymphoma on a recent representative tumor biopsy. OR - (Group 6 and Group 7) mantle cell lymphoma (MCL) histologically confirmed as CD20+ on a recent representative tumor biopsy according to WHO 2016 classification, with evidence of relevant marker-associated cyclin D1 overexpression as determined by immunohistochemistry (IHC) or t (11; 14) Evidence exists. -- A local laboratory report is acceptable, but the tumor block or section must be sent to the central pathology laboratory for confirmation.8Subjects must have received no prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.9Subjects must have one or more measurable lesions as described in the study protocol.10Subjects must be eligible to receive and need to start treatment based on symptoms and/or disease burden as assessed by the investigator.11Subjects must have an ECOG performance status of 0-2 in the Eastern United States Cooperative Oncology Group (ECOG), with the exception of Cohort 6 and Cohort 7, who must have an ECOG performance status of 0-1.12Toxicities from prior anticancer therapy in subjects have resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0) Grade 2 or less (except alopecia). Other eligibility criteria (e.g., laboratory tests, cardiac criteria) must also be met.13At screening, the subject has no current evidence of a primary central nervous system (CNS) tumor or known CNS involvement (including leptomeningeal disease).14Subject has no history of severe allergy or anaphylaxis to anti-CD20 mAb treatment, or known no significant allergy or intolerance to any component or excipient of epcoritamab or any component of the investigational concomitant drug (e.g., lenalidomide, rituximab, etc.).15Subjects must not have undergone autologous stem cell transplantation (ASCT) within 3 months prior to screening and have not received prior allogeneic hematopoietic stem cell transplantation.16Subjects must not receive any chemotherapy or non-investigational antineoplastic agents (other than CD20 mAb) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of epcoritamab (except for Arms 6 and 7, bridging therapy for MCL is allowed, see study protocol).17Subject has no clinically significant cardiovascular disease as described in the study protocol.18Subjects have no clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.19Subjects have no active hepatitis B virus or hepatitis C virus infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result prior to enrollment. Subjects with positive PCR will be excluded.20Subjects have no known history of human immunodeficiency virus infection. Note: Human immunodeficiency virus testing is not required at screening unless required by local guidelines or institutional standards.21Subject has no known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infection of the nail bed) requiring intravenous (IV) treatment within 2 weeks prior to enrollment.22Subject has no significant, uncontrolled concomitant illness that may affect protocol adherence or interpretation of results.23Subject has no history of other prior malignancies, except as described in the study protocol.24If a subject has only 1 target lesion and no other target lesions that have not received radiotherapy, the target lesion cannot have received prior radiotherapy.25Subject does not have > grade 1 neuropathy. Subjects must not have active tuberculosis (TB) or a history of completed active TB treatment within the past 12 months, as described in the study protocol.26Subject has no active (symptomatic) cytomegalovirus (CMV) disease.27Subject has no current autoimmune disease requiring immunosuppressive therapy other than prednisone ≤ 20 mg/day (or equivalent).28Subject has no life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject or put the study outcomes at unreasonable risk.29Subject does not have a current seizure requiring treatment.30Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If the subject has signs/symptoms suggestive of SARS-CoV-2 infection or has a recent known exposure to SARS-CoV infection, they should have molecular testing (e.g., PCR) or 2 negative antigen test results at least 24 hours apart to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic testing should be performed in accordance with local requirements/recommendations.31Subjects who do not meet the eligibility criteria for SARS-CoV-2 infection must be judged to have failed screening and may be re-screened only after meeting the criteria for viral clearance of SARS-CoV-2 infection as described in the study protocol.32Subjects must not have undergone major surgery within 4 weeks prior to the first dose of study drug.33Subject has a life expectancy of > 3 months after receiving standard treatment from the time of enrollment.34Subject has no known history of progressive multifocal leukoencephalopathy (PML).35For all women of childbearing potential; Negative serum pregnancy test (β human chorionic gonadotropin [hCG]) at the screening visit and a negative baseline urine pregnancy test prior to the first dose of study drug.36Female subjects of childbearing potential must use at least 1 protocol-specified method of contraception from 30 days prior to enrollment until at least 12 months after the last dose of study drug. Female subjects of non-childbearing potential do not require contraception.37Female subjects who are not pregnant, lactating, donating eggs (oocytes, oocytes), or considering pregnancy during the study or within 12 months after the last dose of study drug.38If the subject is male and is active sexually active with a female partner of childbearing potential, must agree to use protocol-specified contraception from 30 days prior to enrollment until 12 months after the last dose of study drug.39Male subjects who are not considering fertility or sperm donation during the study or for 12 months after the last dose of study drug.40Subject is not using drugs known to reduce T cell number or activity or other concomitant immunosuppressive medications, excluding up to 20 mg/day of prednisone or equivalent, or medications used for disease control during screening.41Subjects must not have received any investigational drug within 30 days prior to the first dose of study drug or within 5 half-lives of the drug, whichever is longer, or is currently enrolled in another interventional clinical study or has previously been enrolled in this study (the use of drugs approved with emergency authorization, such as anti-SARS-CoV-2 mAbs, is permitted).42Subject has not received a live attenuated vaccine within 28 days prior to screening or is expected to require any live attenuated vaccine for the duration of study enrollment, including at least 3 months after the last dose of study treatment. Coronavirus mRNA and adenovirus vaccines with non-live attenuated vaccines are allowed.43Subjects must have R/R DLBCL, as described in the study protocol.44Subjects must be relapsed/refractory to at least one prior systemic anti-lymphoma therapy (radiotherapy is not considered systemic therapy) containing anti-CD20 monoclonal antibodies. Subjects who have received only prior anti-CD20 monoclonal antibody monotherapy are not eligible.45Subjects must not be refractory to prior CAR-T therapy (defined as best response as stable disease [SD] or disease progression [PD]). Subjects must not have received any CAR-T therapy within 90 days prior to enrollment; Any CAR-T-related toxicity should have resolved for at least 30 days.46Subjects must have failed prior ASCT or be deemed unsuitable for ASCT due to age, performance status, comorbidities, and/or inadequate response, or refuse ASCT.47Subjects must not have a documented history of lenalidomide refractory and must be suitable for lenalidomide treatment in the opinion of the investigator, as described in the study protocol.48Subjects must be willing to receive aspirin prophylaxis or anticoagulation therapy to prevent thromboembolic events (or according to local lenalidomide dosing guidelines).49Female subjects of childbearing potential must practice at least 2 protocol-specified methods of contraception that adhere to from 30 days prior to enrollment until at least 12 months after the last dose of study drug. Female subjects of non-childbearing potential do not require contraception.50Subject is willing to comply with a pregnancy risk minimization program associated with lenalidomide treatment.51Subjects must not have been exposed to lenalidomide within 12 months prior to screening.52Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).53Subjects must agree not to donate blood while receiving dosing, during interruptions in dosing, and for at least 28 days after the last dose of lenalidomide.54Subjects must have R/R (as defined by criterion #43) DLBCL.55Subjects must have received at least 1 line of prior therapy, which must include an anti-CD20 monoclonal antibody in combination with another systemic therapy (radiotherapy is not considered systemic therapy).56Subjects must have received prior CAR-T cell therapy, but for subjects who achieved remission after prior CAR-T therapy, treatment not less than 90 days prior to the first dose of epcoritamab or, for subjects refractory to CAR-T, no less than 30 days prior to the first dose of epcoritamab as described in the study protocol.57Subjects must have failed prior ASCT or be deemed unsuitable for ASCT due to age, performance status, comorbidities, and/or inadequate response, or refuse ASCT.58Subjects must not have a documented record of lenalidomide refractory and must be suitable for lenalidomide therapy in the opinion of the investigator.59Subjects must have received no prior treatment with ibrutinib and must be considered suitable for treatment with ibrutinib by the investigator.60Subjects must not have been exposed to lenalidomide within 12 months prior to screening.61Subjects must not have a known bleeding disorder (e.g., von Willebrand VW) or hemophilia.62Subjects must not require treatment with strong cytochrome P450 (CYP) 3A inhibitors.63Subjects must not consume grapefruit, grapefruit products, Seville oranges (including jams containing Seville oranges), or star fruit for at least 3 days prior to Cycle 1 Day 1.64Subjects must be willing to receive aspirin prophylaxis or anticoagulation therapy to prevent thromboembolic events (or according to local lenalidomide dosing guidelines).65Female subjects of childbearing potential must practice at least 2 protocol-specified methods of contraception that adhere to from 30 days prior to enrollment until at least 12 months after the last dose of study drug. Female subjects of non-childbearing potential do not require contraception.66Subject is willing to comply with a pregnancy risk minimization program associated with lenalidomide treatment.67Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).68Subjects must agree not to donate blood while receiving dosing, during dosing interruptions, and for at least 28 days after the last dose of ibrutinib or lenalidomide.69Subjects must be newly diagnosed treatment-naïve (excluding prior therapy for transformed indolent lymphoma) DLBCL.70In the opinion of the investigator, subjects must be suitable for treatment with vepotuzumab, rituximab, cyclophosphamide, doxorubicin, and prednisone.71Subjects must have an International Prognostic Index score of 2-5.72Subjects must have R/R (as defined by criterion #43) DLBCL.73Subjects must be relapsed/refractory to at least one prior systemic anti-lymphoma therapy (radiotherapy is not considered systemic therapy) containing anti-CD20 monoclonal antibodies. Subjects who have received only prior anti-CD20 monoclonal antibody monotherapy are not eligible.74Subjects must not be refractory to prior CAR-T therapy (defined as best response as stable disease [SD] or disease progression [PD]). Subjects must not have received any CAR-T therapy within 90 days prior to enrollment; Any CAR-T-related toxicity should have resolved for at least 30 days.
Exclusion criteria
- Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20. Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met. Diagnosis of High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
- 1Subjects must have failed prior ASCT or be deemed unsuitable for ASCT due to age, performance status, comorbidities, and/or inadequate response, or refuse ASCT.2Female subjects of childbearing potential must use at least 2 protocol-specified methods of contraception (at least one highly effective method and one effective method) concurrently within 30 days prior to enrollment until at least 12 months after the last dose of epcoritamab.3Subjects must be willing to comply with the pregnancy risk minimization program associated with CC-99282 treatment.4Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).5Subjects must not have received prior treatment with CC-99282 or CC-220 (iberdomide).6Subjects must agree not to donate blood while receiving CC-99282 dosing, during dosing interruptions, and for at least 28 days after the last dose of CC-99282.7Subjects must have R/R (as defined by criterion #43) FL.8Subjects must have stage II-IV disease.9The investigator must determine if the subject needs to start treatment based on symptoms and/or disease burden.10Subjects must have relapsed/refractory to at least one prior systemic anti-lymphoma therapy (radiotherapy is not considered systemic therapy) containing anti-CD20 monoclonal antibodies. Subjects who have received only prior anti-CD20 monoclonal antibody monotherapy are not eligible.11Subjects must not be refractory to prior CAR-T therapy (defined as best response as stable disease [SD] or disease progression [PD]). Subjects must not have received any CAR-T therapy within 90 days prior to enrollment; Any CAR-T-related toxicity should have resolved for at least 30 days.12Female subjects of childbearing potential must use at least 2 protocol-specified methods of contraception (at least one highly effective method and one effective method) concurrently within 30 days prior to enrollment until at least 12 months after the last dose of epcoritamab.13Subjects must be willing to comply with the pregnancy risk minimization program associated with CC-99282 treatment.14Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).15Subjects must not have received prior treatment with CC-99282 or CC-220 (iberdomide).16Subjects must agree not to donate blood while receiving CC-99282 dosing, during dosing interruptions, and for at least 28 days after the last dose of CC-99282.17Subjects must have R/R (as defined by criterion #43) FL.18Subjects must have stage II-IV disease.19The investigator must determine if the subject needs to start treatment based on symptoms and/or disease burden.20Subjects must have relapsed/refractory to at least one prior systemic anti-lymphoma therapy (radiotherapy is not considered systemic therapy) containing anti-CD20 monoclonal antibodies. Subjects who have received only prior anti-CD20 monoclonal antibody monotherapy are not eligible.21Subjects must not be refractory to prior CAR-T therapy (defined as best response as stable disease [SD] or disease progression [PD]). Subjects must not have received any CAR-T therapy within 90 days prior to enrollment; Any CAR-T-related toxicity should have resolved for at least 30 days.22Female subjects of childbearing potential must use at least 2 protocol-specified methods of contraception (at least one highly effective method and one effective method) concurrently within 30 days prior to enrollment until at least 12 months after the last dose of epcoritamab.23Subjects must be willing to comply with the pregnancy risk minimization program associated with CC-99282 treatment.24Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).25Subjects must not have received prior treatment with CC-99282 or CC-220 (iberdomide).26Subjects must agree not to donate blood while receiving CC-99282 dosing, during dosing interruptions, and for at least 28 days after the last dose of CC-99282.27Subjects must have R/R (defined in criterion #43) MCL.28Subjects must have an absolute lymphocyte count of ≤ 50 × 10^9/L during screening and must ≤ 10 × 10^9/L by Cycle 1 Day 1 (bridging therapy may be required and permitted).29Subjects must have received at least 1 prior MCL therapy, including an anti-CD20 monoclonal antibody in combination with another systemic therapy (radiotherapy is not considered systemic therapy).30Subjects must not be refractory to prior CAR-T therapy (defined as best response as stable disease [SD] or disease progression [PD]). Subjects must not have received any CAR-T therapy within 90 days prior to enrollment; Any CAR-T-related toxicity should have resolved for at least 30 days.31The investigator must consider the subject suitable for treatment with ibrutinib.32Subjects must have received no prior BTKi therapy.33Subjects must not have a known bleeding disorder (e.g., von Willebrand VW) or hemophilia.34Subjects must not require treatment with strong cytochrome P450 (CYP) 3A inhibitors.35Subjects must not consume grapefruit, grapefruit products, Seville oranges (including jams containing Seville oranges), or star fruit for at least 3 days prior to Cycle 1 Day 1.36Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).37Subjects must have R/R (defined in criteria #43 and 35) MCL.38Subjects must have an absolute lymphocyte count of 50 × 10^9/L during screening ≤and must ≤ 10 × 10^9/L by Cycle 1 Day 1 (bridging therapy may be required and permitted).39Subjects must have received at least 1 prior MCL therapy, including an anti-CD20 monoclonal antibody in combination with another systemic therapy (radiotherapy is not considered systemic therapy).40Subjects must not be refractory to prior CAR-T therapy (defined as best response as stable disease [SD] or disease progression [PD]). Subjects must not have received any CAR-T therapy within 90 days prior to enrollment; Any CAR-T-related toxicity should have resolved for at least 30 days.41The investigator must consider the subject to be suitable for treatment with ibrutinib and venecla.42Subjects must have received no prior BTKi therapy.43Subjects must not have a known bleeding diathesis (e.g., von Willebrand disease) or hemophilia.44Subjects must not require treatment with a strong cytochrome P450 (CYP) 3A inhibitor and must not have received a strong CYP3A inhibitor for at least 7 days prior to Cycle 1 Day 1.45Subjects must not consume grapefruit, grapefruit products, Seville oranges (including jams containing Seville oranges), or star fruit for at least 3 days prior to Cycle 1 Day 1.46Subjects must not have received prior treatment with BCL-2 inhibitors.47Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).48Subjects must have treatment-naïve MCL disease.49Subjects must have an absolute lymphocyte count of ≤ 50 × 10^9/L during screening and must ≤ 10 × 10^9/L by Cycle 1 Day 1 (bridging therapy may be required and permitted).50Subjects must refuse ASCT, or have not undergone ASCT transplantation (due to age, performance status, comorbidities) or have high-risk disease characteristics (e.g., TP53 variant [deletion/mutation], Ki-67 > 30%, blast-like/pleomorphic variant).51The investigator must consider the subject to be suitable for treatment with ibrutinib and venecla.52Subjects must not have a known bleeding disorder (e.g., von Willebrand VW) or hemophilia.53Subjects must not require treatment with strong cytochrome P450 (CYP) 3A inhibitors.54Subjects must not consume grapefruit, grapefruit products, Seville oranges (including jams containing Seville oranges), or star fruit for at least 3 days prior to Cycle 1 Day 1.55Subjects must be able to swallow capsules and must not have any disease that significantly affects gastrointestinal function (e.g., gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Daniel Morillo Giles
Status
Recruiting
Condition(s) Treated at Site
Lymphoma