Study on Rituximab and Bendamustine, Rituximab and Ibrutinib, or Ibrutinib Alone for Treating Older Patients with Untreated Chronic Lymphocytic Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01886872
This clinical trial is comparing three different treatment options to see which works best for older patients with chronic lymphocytic leukemia (CLL) who have not received treatment before. The study involves using rituximab with bendamustine, rituximab with ibrutinib, or ibrutinib alone.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out which treatment combination is most effective for older patients with chronic lymphocytic leukemia (CLL) who have not been treated before. The treatments being tested are rituximab with bendamustine, rituximab with ibrutinib, and ibrutinib alone. Rituximab is a type of protein that targets cancer cells, bendamustine is a chemotherapy drug, and ibrutinib is a medication that blocks certain enzymes needed for cancer cell growth. The study aims to determine which treatment provides the longest period without the cancer getting worse and which has the best overall survival rates.
Description
The main goal of this study is to see if any of the three treatment options can help patients live longer without their cancer getting worse. The study will also look at how well each treatment works in terms of overall survival, response rates, and how long the response lasts. Researchers will also study the side effects and how well patients tolerate each treatment.
Participants will be randomly assigned to one of three groups:
- Group 1: Rituximab and bendamustine given through an IV every 28 days for up to 6 cycles.
- Group 2: Ibrutinib taken as a pill daily.
- Group 3: Ibrutinib taken daily with rituximab given through an IV on specific days.
Throughout the study, participants will have regular check-ups, including blood tests, bone marrow tests, and CT scans. After finishing the treatment, participants will be followed up every 6 months for up to 10 years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 65 years or older.
- Diagnosed with chronic lymphocytic leukemia (CLL) with specific blood and cell characteristics.
- Must not have received any prior treatment for CLL, except for certain steroids or treatments for autoimmune complications.
- Must have a certain level of cancer activity or symptoms that require treatment.
- Must have good overall health with an ECOG performance status of 0-2.
- Must not have active hepatitis B or be on certain blood thinners.
- Must not have severe heart conditions or recent heart attacks or strokes.
- Must not have a history of Richter's transformation or prolymphocytic leukemia.
- Must not have uncontrolled infections or require certain medications that interact with the study drugs.
- Must have adequate blood counts and organ function as determined by specific tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 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 |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
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