A safety and Tolerability Study of INCB053915 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma

Updated on 10 May 2022
b-cell lymphoma


The purpose of this study is to evaluate the safety and tolerability of INCB053914 in combination with INCB050465 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).



For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Condition Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell
Clinical Study IdentifierTX218021
Last Modified on10 May 2022


Yes No Not Sure

Inclusion Criteria

Relapsed or refractory DLBCL, histologically documented, have received at least 2, but no more than 5 prior systemic treatment regimens (eg, an anit-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligible for further treatment with standard of care
Willing to undergo pretreatment and on-treatment incisional or excisional biopsy of nontarget adenopathy or extranodal lesions. Provision of the most recent, available archived tumor biopsy may satisfy the pretreatment biopsy
Measurable disease as defined by the Lugano classification criteria
≥ 1 measurable nodal lesion (≥ 1.5 cm in longest dimension) or ≥ 1 measurable extranodal lesion (> 1 cm in longest dimension) on CT scan or MRI
≥ 1 PET-avid lesion
Eastern Cooperative Oncology Group performance status 0 to 2
Willingness to avoid pregnancy or fathering children based on protocol-defined the criteria

Exclusion Criteria

Laboratory values outside the protocol-defined range at screening unless approved by the medical monitor
Primary mediastinal (thymic) large B-cell lymphoma or Richter's Syndrome
Known brain or central nervous system metastases or history of uncontrolled seizures
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment
Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment
Use of immunosuppressive therapy following allogenic transplant within 28 days of the first dose of study treatment
Prior treatment with a PIM inhibitor, selective PI3Kδ inhibitor (eg, idelalisib), or a pan-PI3K inhibitor
Receipt of anticancer medications, therapies, or investigational drugs within protocol-defined intervals before the date of the first dose of study treatment
Current or previous other malignancy within 3 years of study entry, except cured (or treated with curative intent and no evidence of disease) basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval
History of liver function abnormality requiring investigation and/or treatment (eg, due to excessive alcohol or drug-induced liver injury)
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease
Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment, and exposure to a live vaccine within 30 days of study treatment administration
Known HIV infection or evidence of HBV or HCV infection
History of stroke or intracranial hemorrhage within 6 months of the date of study treatment administration
History of clinically significant or uncontrolled cardiac disease
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
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