Phase 2 Trial of Obinutuzumab and CC-99282 for Patients with Untreated High Tumor Burden Follicular Lymphoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06108232
This clinical trial is testing whether a combination of the drugs obinutuzumab and CC-99282 can help control follicular lymphoma in patients who have not received any previous treatment and have a high tumor burden.
Patient Parameters
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Program Overview
The aim of this study is to find out if the combination of obinutuzumab and CC-99282 can effectively treat follicular lymphoma in patients who have not been treated before and have a high tumor burden. Researchers will look at how well the treatment works by measuring the complete response rate after six cycles of treatment. They will also assess other outcomes like overall response rate, duration of response, time to next treatment, and survival rates. Additionally, the study will explore the quality of life for patients receiving this treatment and identify any biomarkers related to treatment response and resistance.
Description
This study is focused on evaluating the effectiveness and safety of combining obinutuzumab with CC-99282 for treating follicular lymphoma in patients who have not received prior treatment and have a high tumor burden. The primary goal is to determine the complete response rate after six cycles of treatment. Secondary goals include assessing the overall response rate, duration of response, time to next treatment, progression-free survival, overall survival, and safety of the treatment. The study will also explore biomarkers that may predict response to treatment and mechanisms of resistance, as well as the impact on patients' quality of life.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with follicular lymphoma grade 1-3a.
- No previous systemic treatment for lymphoma.
- Disease is at stage II, III, or IV.
- Aged 18 years or older.
- Performance status of 0 to 2 on the ECOG scale, indicating full activity or some restriction in strenuous activities.
- High tumor burden based on specific medical criteria.
- Have a large tumor mass over 7 cm or multiple tumor sites over 3 cm.
- Experience at least one B symptom like fever, night sweats, or significant weight loss.
- Have symptomatic spleen enlargement or risk of organ compression.
- Have certain blood count levels due to bone marrow involvement.
- Have measurable disease with specific tumor sizes on scans.
- Have adequate organ and marrow function based on blood tests.
- Agree to follow pregnancy prevention guidelines and not donate blood during the study.
- Women must not be breastfeeding and must use effective contraception.
- Men must use condoms and not donate sperm during the study.
- Must sign an informed consent document and understand the study requirements.
Exclusion Criteria
- Have active central nervous system lymphoma or leptomeningeal disease.
- Have had another cancer within the last 3 years, except for certain skin or cervical cancers.
- Have a serious illness or medical condition that could affect safety or study results.
- Have uncontrolled HIV, Hepatitis B or C, or other significant infections.
- Have a history of immunodeficiency or are on systemic immunosuppressant therapy.
- Require treatment with strong CYP3A inhibitors.
- Have significant heart disease or abnormal heart rhythms.
- Have a history of stroke or brain bleeding within the last 6 months.
- Have received live vaccines within 4 weeks of the study.
- Are pregnant or breastfeeding.
- Have had major surgery within 28 days or minor surgery within 3 days of the study.
- Have a life expectancy of less than 6 months.
- Have severe neuropathy or prior exposure to certain medications.
- Have difficulty swallowing or absorbing oral medication.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have a history of severe skin reactions or blood clots.
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