Testing the Addition of Venetoclax to Standard Treatment for Older Patients with Untreated Chronic Lymphocytic Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03737981
This study is exploring whether adding a new drug, venetoclax, to the usual treatment of ibrutinib and obinutuzumab can help prevent chronic lymphocytic leukemia from returning in older patients who have not been treated before. It also examines if patients can stop taking ibrutinib after a year if their leukemia is undetectable.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This phase III trial is testing if adding venetoclax to the standard treatment of ibrutinib and obinutuzumab can better prevent chronic lymphocytic leukemia (CLL) from coming back in older patients who haven't had treatment before. The study also looks at whether patients who show no signs of CLL after a year can stop taking ibrutinib. Ibrutinib works by blocking enzymes that cancer cells need to grow. Obinutuzumab is an immunotherapy that helps the immune system fight cancer. Venetoclax blocks a protein that cancer cells need to survive. The combination might be more effective than the usual treatment alone.
Description
The main goal of this study is to compare how long patients live without their leukemia getting worse when treated with either the standard treatment (ibrutinib and obinutuzumab) or the new combination (ibrutinib, venetoclax, and obinutuzumab). Researchers will also look at how well the leukemia responds to these treatments and how safe they are.
Patients will be randomly assigned to one of two groups:
-
Group 1: Patients will take ibrutinib daily and receive obinutuzumab through an IV on specific days for up to 14 cycles (each cycle is 28 days). After that, they will continue taking ibrutinib daily unless the leukemia progresses or they experience unacceptable side effects.
-
Group 2: Patients will take ibrutinib daily, receive obinutuzumab through an IV on specific days, and start taking venetoclax daily from the third cycle. This treatment will also last for 14 cycles. Afterward, all patients will take ibrutinib for one more cycle. If their leukemia is undetectable, they will be monitored every few months without further treatment. If not, they will continue taking ibrutinib daily.
After finishing the study treatment, patients will have follow-up visits every six months for up to 10 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Must have a certain number of B-cells in the blood or lymph nodes.
- Must provide a blood sample for specific testing before joining the study.
- Must be at intermediate or high risk according to specific medical criteria.
- Must meet certain health conditions that require treatment, such as anemia, large lymph nodes, or specific symptoms like weight loss or fever.
- Must be 65 years or older.
- Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
- Must have adequate blood counts and organ function.
- Must not have active hepatitis B or C, or must have these conditions under control.
- Must be able to swallow pills and not have conditions affecting digestion.
- Must be able to take certain medications to prevent tumor lysis syndrome.
- Must have completed certain treatments and tests before re-registering for the study.
Exclusion Criteria
- Must not have had previous treatment for CLL/SLL, except for specific cases like palliative steroids.
- Must not have a history of certain types of leukemia or heart conditions.
- Must not have had a heart attack, stroke, or major bleeding in the past six months.
- Must not be on certain blood thinners or medications that affect liver enzymes.
- Must not require high doses of steroids.
- Must not have uncontrolled infections or allergies to specific study drugs.
- Must not have had major surgery recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| 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 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 |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.