Study on Obinutuzumab with or without Umbralisib, Lenalidomide, or Chemotherapy for Treating Relapsed or Hard-to-Treat Follicular Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03269669
This clinical trial is exploring different combinations of treatments, including obinutuzumab, umbralisib, lenalidomide, and chemotherapy, to see which works best for patients with follicular lymphoma that has returned or is not responding to treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out how well different combinations of treatments work for patients with follicular lymphoma that has come back or is not responding to treatment. The treatments being tested include obinutuzumab, which is an immunotherapy that may help the immune system fight cancer, umbralisib, which may block cancer cell growth, lenalidomide, which is a biological therapy that can affect the immune system, and various chemotherapy drugs that work to stop cancer cells from growing and spreading. The study aims to determine if these treatments, alone or in combination, are effective in treating this type of lymphoma.
Description
The main goal of this study is to compare how well different treatment combinations work in achieving a complete response in patients with relapsed or hard-to-treat follicular lymphoma. The study will look at how well the treatments work after up to 6 cycles, using PET/CT scans to measure the response.
Secondary goals include:
- Understanding how a specific risk score (m7-FLIPI) relates to treatment outcomes and progression-free survival.
- Estimating how long patients remain in complete response after 30 months.
- Evaluating the best response, progression-free survival, duration of response, and overall survival with each treatment combination.
- Assessing the side effects of each treatment.
- Comparing non-invasive blood tests with standard tumor tests to predict treatment outcomes.
- Examining the relationship between active lymphoma detected by scans and tumor DNA in the blood.
Participants will be randomly assigned to one of three treatment groups:
- Group 1 (Closed to New Participants): Obinutuzumab given by IV and umbralisib taken orally daily for up to 12 cycles.
- Group 2: Obinutuzumab by IV and lenalidomide taken orally for 21 days in each 28-day cycle, for up to 12 cycles.
- Group 3:
- If previously treated with bendamustine: Obinutuzumab by IV, cyclophosphamide, doxorubicin, vincristine by IV, and prednisone orally for 5 days. Obinutuzumab is given every 21 or 28 days for up to 12 cycles, and chemotherapy every 21 days for 6 cycles.
- If previously treated with CHOP: Obinutuzumab by IV and bendamustine by IV over 60 minutes on days 1 and 2, every 28 days for up to 6 or 12 cycles.
All participants will have biopsies, heart function tests, and regular PET/CT scans and blood tests throughout the study. After treatment, follow-up visits will occur every 3 months for 2 years, then every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria
- Must have follicular lymphoma (grade I, II, or IIIa) confirmed at diagnosis and relapse, with disease visible on PET/CT scans.
- Must have a PET/CT scan and bone marrow biopsy within 42 days before joining the study.
- Must need treatment as determined by the doctor.
- Must have relapsed within 2 years after completing first chemotherapy (CHOP or bendamustine) with anti-CD20 therapy.
- Must have received only one course of chemotherapy with at least 3 cycles of CHOP or bendamustine.
- Must be 18 years or older.
- Must have a performance status score of 0, 1, or 2, indicating good overall health.
- Must have adequate blood counts and organ function as determined by specific tests.
- Must not have active hepatitis B or C, or HIV unless well-controlled.
- Must agree to use birth control if of childbearing potential.
- Must be willing to take preventive medication if assigned to lenalidomide.
- Must not have another active cancer, except for certain skin or cervical cancers.
- Must have a complete medical history and physical exam within 28 days before joining the study.
- Must agree to participate in biobanking of tissue samples for future research.
Exclusion Criteria
- Must not have lymphoma involving the central nervous system.
- Must not have had prior treatment with PI3K inhibitors or lenalidomide.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
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