Accelerated Venetoclax Escalation for Chronic Lymphocytic Leukemia
(SAVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a faster method to increase doses of venetoclax, a medication for certain cancers, in individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The researchers aim to determine if patients can safely manage a quicker dose escalation over five days instead of the usual five weeks. Participants may also receive additional treatments like rituximab or obinutuzumab. Individuals with a confirmed diagnosis of CLL or SLL, experiencing symptoms that affect daily life, such as significant fatigue or spleen swelling, may be suitable for this trial. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to contribute to groundbreaking cancer research.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop all current medications. However, you cannot take medications or foods that are strong inhibitors or inducers of CYP3A starting 1 week before the first dose of venetoclax. If you're on targeted therapies, a washout period of at least five half-lives is required. Corticosteroid therapy (prednisone or equivalent ≤20 mg daily) is allowed.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications or foods that strongly affect CYP3A enzymes at least one week before starting venetoclax. If you're on targeted therapies, a washout period (time without taking certain medications) of at least five half-lives is needed, unless otherwise approved by the study investigator.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that venetoclax is generally well-tolerated by patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Studies have identified some common side effects, such as low blood cell counts, diarrhea, and nausea, which were mostly mild to moderate.
When combined with other treatments like obinutuzumab or rituximab, venetoclax maintains a similar safety profile. Patients might experience the same side effects, but these are usually manageable with proper care.
The FDA has already approved venetoclax for use in CLL, indicating a strong safety record when used as directed. Ongoing research is exploring a faster way to increase the dose, so safety data is still being collected. However, past findings provide a hopeful indication of its safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about accelerated venetoclax escalation for chronic lymphocytic leukemia (CLL) because it aims to rapidly increase the dosage of venetoclax, potentially achieving full therapeutic effects much faster than traditional methods. Unlike standard CLL treatments, which usually require gradual dosage increases over several weeks to minimize the risk of tumor lysis syndrome (TLS), this approach seeks to safely escalate the dose over just five days. Additionally, venetoclax itself is a BCL-2 inhibitor, which works differently from many traditional CLL treatments by directly inducing cancer cell death. This accelerated approach could significantly reduce the time patients spend in the hospital and allow for quicker transitions to at-home care, potentially improving quality of life and treatment outcomes.
What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?
Research has shown that venetoclax, the primary treatment in this trial, effectively treats chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Studies have found that venetoclax targets a protein called BCL2, which helps cancer cells survive. By blocking BCL2, venetoclax helps kill these cancer cells. In one study, 77% of patients with CLL that had returned or didn't respond to other treatments experienced a positive response to venetoclax. This drug has proven effective even in patients with high-risk genetic changes, such as a specific type of CLL called del(17p). Overall, venetoclax has a strong track record of helping patients with these blood cancers. Participants in this trial may also receive rituximab or obinutuzumab alongside venetoclax, as determined by their doctor.45678
Who Is on the Research Team?
Jennifer Crombie, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants must have symptoms like anemia, weight loss, fatigue, fevers without infection, night sweats, and adequate organ function. They should not have had a recent stem cell transplant or other cancers and must be willing to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax with accelerated dose increases over 5 days, followed by daily administration at home. Some may also receive rituximab or obinutuzumab.
Active Follow-up
Participants are actively followed for approximately 3 months to monitor safety and effectiveness.
Long-term Follow-up
Participants enter a long-term follow-up period where they will be observed for a maximum of 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Obinutuzumab
- Rituximab
- Venetoclax
Venetoclax is already approved in United States, European Union for the following indications:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Acute myeloid leukemia (AML)
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Acute myeloid leukemia (AML)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor