Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burd… (NCT06108232) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma
United States33 participantsStarted 2024-03-15
Plain-language summary
To learn if obinutuzumab in combination with CC-99282 can help to control previously untreated, high tumor burden FL
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients must meet the following criteria for study entry:
* Histologically diagnosed follicular lymphoma grade 1-3a
* Have no prior systemic treatment for lymphoma
* Stage II, III or IV disease
* Age ≥18 years
* Performance status ≤2 on the ECOG scale
* High-tumor burden disease based on GELF criteria36
* A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter
* At least 3 nodal or extranodal sites ≥ 3 cm in diameter
* Presence of at least one B symptom
* Fever (\>38 ℃), night sweats, weight loss \> 10% in the past 6 months
* Symptomatic splenomegaly (or size \>13cm)
* Impending organ compression or involvement (ureteral, orbital, gastrointestinal)
* Any of the following cytopenias due to bone marrow involvement of lymphoma
* Hemoglobin ≤ 10 g/dL
* Platelets ≤ 100 x 109/L
* Absolute neutrophil count (ANC) \< 1.5x109/L
* Pleural effusion or ascites
* Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion \> 1 cm in longest diameter by CT, PET/CT, and/or MRI
* Bulky disease is defined as \> 10 cm in its greater diameter
* Patients must have adequate organ and marrow function as defined below:
* Total bilirubin ≤ 1.5 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin \> 5)
* AST and ALT ≤ 3x upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 ULN
* Creatinine clearance \>50 ml/min calculated by modified Cockcroft-Gault formula
* Blood counts below if witho…
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: through study completion; an average of 1 year.