Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cel… (NCT02992522) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
United States22 participantsStarted 2017-02-21
Plain-language summary
This phase I study studies the side effects and best dose of venetoclax and lenalidomide when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or not responding to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Prior venetoclax or other BCL-2 family inhibitors or prior lenalidomide is not permitted
* Creatinine clearance \>= 50 ml/min using a 24 hour creatinine clearance or estimated creatinine clearance using the Cockcroft-Gault equation
* Bilirubin =\< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet \>= 75,000/mm\^3
* Unless related to bone marrow involvement with disease, in which case platelets must be \>= 50,000/mm\^3
* Recovery to =\< grade 1 from all toxicities associated with prior therapy except alopecia
* Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of any of the following subtypes recognized by the World Health Organization (WHO) classification: Burkitt lymphoma, B-cell lymphoma unclassifiable with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma, or follicular lymphoma; patients with evidence of histological transformation to diffuse large B-cell lymphoma from indolent NHL are eligible
* At least one prior therapy; prior autologous stem cell transplant is permitted; patients with aggressive lymphoma who have not received high-dose therapy (HDT)/autologous stem cell transplantation (ASCT) must be ineligible for HDT/ASCT; prio…
What they're measuring
1
MTD defined as the highest level at which no more than 6 patients experience a DLT assessed by National Cancer Institute Common Terminology Criteria of Adverse Events version 4