Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Fol… (NCT04450173) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma
United States40 participantsStarted 2021-02-24
Plain-language summary
This phase II trial studies how well obinutuzumab, ibrutinib, and venetoclax work in treating patients with previously untreated stage II-IV follicular lymphoma. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib and venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab, ibrutinib, and venetoclax together may work better in treating follicular lymphoma compared to each drug alone.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
* Able and willing to provide written informed consent and to comply with the study protocol
* Bi-dimensionally measurable disease, with at least one mass lesion \>= 2 cm in longest diameter by CT, PET/CT, and/or magnetic resonance imaging (MRI)
* Must be in need of therapy as evidenced by at least one of the following criteria:
* Bulky disease defined as:
* A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter or,
* At least 3 nodal or extranodal sites \>= 3 cm in diameter
* Presence of at least one B symptom:
* Fever (\> 38 Celsius \[C\]) not due to infectious etiology
* Night sweats
* Weight loss \> 10% in the past 6 months
* Fatigue due to lymphoma
* Splenomegaly (\> 13 cm)
* Compression syndrome (ureteral, orbital, gastrointestinal)
* Any of the following cytopenias, due to lymphoma:
* Hemoglobin =\< 10 g/dL
* Platelets =\< 100 x 10\^9/L
* Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
* Pleural or peritoneal effusion
* Lactate dehydrogenase (LDH) \> upper limit of normal (ULN) or beta (B)2 microglobulin \> ULN
* Other lymphoma-mediated symptoms as determined by the treating physician
* Stage II, III, or IV disease
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Absolute neutrophil count (ANC) \> 1.0 x 10\^9/L
* Platelet count \> 50 x 10\^9/L
* Prothrombin time (PT)/international norm…