Study Comparing Venetoclax and Rituximab with Ibrutinib and Rituximab for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04840602
This clinical trial is testing two different treatment combinations for patients with Waldenstrom's Macroglobulinemia, a type of blood cancer. The study compares the effects of venetoclax and rituximab against the usual treatment of ibrutinib and rituximab to see which works better for patients who have not received prior treatment.
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Program Overview
This study aims to find out if the combination of venetoclax and rituximab is more effective than the standard treatment of ibrutinib and rituximab for patients with Waldenstrom's Macroglobulinemia, a type of blood cancer. Ibrutinib works by blocking certain enzymes that help cancer cells grow, while rituximab is an antibody that helps the immune system target cancer cells. Venetoclax blocks a protein that cancer cells need to survive. The trial will compare how well these treatments work in shrinking the cancer and how long patients stay free from disease progression.
Description
The main goal of this study is to compare how well patients respond to two different treatment combinations for Waldenstrom's Macroglobulinemia. One group will receive ibrutinib and rituximab, while the other group will receive venetoclax and rituximab. Researchers will look at how many patients achieve a very good partial response or better, and how long they remain free from disease progression.
Secondary goals include comparing overall response rates, complete response rates, and overall survival between the two groups. The study will also evaluate the safety of each treatment combination and how quickly patients achieve a very good partial response.
Patients will be randomly assigned to one of two groups. In the first group, patients will take ibrutinib daily and receive rituximab infusions during specific cycles. In the second group, patients will take venetoclax daily and receive rituximab infusions during the same cycles. If the disease progresses, patients may switch to the other treatment combination.
Participants will undergo regular scans and blood tests to monitor their response to treatment. After completing the study treatment, patients will be followed every few months to track their health and any disease progression.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of Waldenstrom's Macroglobulinemia or Lymphoplasmacytic Lymphoma.
- Must have measurable disease, such as a specific level of IgM protein in the blood.
- Must need treatment for symptoms like anemia, nerve problems, or other related conditions.
- Must not have had previous systemic therapy, except for rituximab if it was given more than 6 months ago.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
- Must have adequate kidney and liver function based on specific blood tests.
- Must not have any active infections or other serious medical conditions.
- Must not be pregnant or nursing and must agree to use effective contraception if of childbearing potential.
- Must be able to swallow pills and not have any conditions that affect drug absorption.
- Must not have a history of intolerance to rituximab.
- Must be willing to participate in specimen banking for future research.
- Must provide informed consent to participate in the study.
- Must meet specific criteria if switching treatments due to disease progression.
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