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New treatment option for Lymphoplasmacytic Lymphoma
Official title Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
ClinicalTrials.gov ID: NCT04840602
What this study is testing
What is Ibrutinib?
Ibrutinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lymphoplasmacytic lymphoma.
Also referred to as BTK Inhibitor PCI-32765, CRA 032765.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have...
- IgM Spike: ≥ 500 mg/dL (≥ 5 g/L)
- Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as...
- Testing to establish baseline disease status must be performed within 28 days prior to registration
- Participants must have at least one of the criteria to require therapy for WM including:
See the full eligibility criteria
Who can join
- Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have measurable disease as determined by IgM protein quantification.
- IgM Spike: ≥ 500 mg/dL (≥ 5 g/L)
- Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as the lymph nodes or spleen. Note: all participants must have measurable...
- Testing to establish baseline disease status must be performed within 28 days prior to registration
- Participants must have at least one of the criteria to require therapy for WM including:
- Anemia
- Thrombocytopenia
- Neuropathy related to WM
- Symptomatic hyperviscosity or serum viscosity levels ≥ 4.0 centipoises
- WM associated glomerulonephritis or renal disease, bulky disease, or constitutional symptoms
- Constitutional symptoms can be described as:
- Unintentional weight loss \>= 10% within the previous 6 months prior to screening
- Fevers higher than 100.5 degrees Fahrenheit (F) or 38.0 degrees Celsius (C) for 2 or more weeks prior to screening without evidence of infection
- Night sweats for more than 1 month prior to screening without evidence of infection
- Clinically relevant fatigue which is not relieved by rest due to WM
- Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug will be excluded from the...
- Participants must not have had prior systemic therapy. Prior therapy with rituximab will be allowed as long as the last rituximab dose was at least 6 months prior to registration
- Participants must be \>= 18 years of age
- Participants must have history and physical exam within 28 days prior to registration
- Participants must have Zubrod performance status =\< 2
- Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>= 30 mL/min. Values must be obtained within 14 days prior to registration
- Total bilirubin =\< 1.5 x IULN (institutional upper limit of the norm) (within 14 days prior to registration)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x IULN (within 14 days prior to registration)
- Alkaline phosphatase =\< 3 x IULN (within 14 days prior to registration)
- Platelet count \>= 50,000 cells/mm\^3 (within 14 days prior to registration)
- NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
- Hemoglobin \>= 7.0 g/dL (within 14 days prior to registration)
- NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
- Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 (within 14 days prior to registration)
- NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
- Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within...
- Participants must be able to take and swallow oral medication (capsules) whole. Participants may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the...
- Participants must not be intolerant to rituximab
- Participants must not have known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding localized skin and nail bed fungal infections) at study enrollment, or any major episode of...
- Participants must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). Hepatitis C...
- Participants must not consume grapefruit, Seville oranges or starfruit within 3 days prior to the first dose of venetoclax
- Participants must not be pregnant or nursing because venetoclax has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. A woman is considered to be of "reproductive...
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is...
- Participants must be offered the opportunity to participate in specimen banking
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making...
- As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review...
- CROSSOVER CRITERIA: Participants must have been registered and received treatment in the IR/Z or VR arm and must show progression of disease at any time during cycles 3-24
- CROSSOVER CRITERIA: In case of transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome the participants will not undergo registration step 2 crossover and will be taken off the study
- CROSSOVER CRITERIA: Participants must have Zubrod performance status =\< 2
- CROSSOVER CRITERIA: Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>= 30 mL/min. Values must be obtained within 14 days prior to registration
- CROSSOVER CRITERIA: Participants must have no evidence of marked hepatic dysfunction on any recent liver function tests within 14 days prior to registration
- CROSSOVER CRITERIA: Platelet count \>= 50,000 cells/mm\^3 (without within 14 days prior to registration)
- NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
- CROSSOVER CRITERIA: Hemoglobin \>= 7.0 g/dL (without within 14 days prior to registration)
- NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
- CROSSOVER CRITERIA: Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 (without within 14 days prior to registration)
- NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Irvine, California, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Nampa, Idaho, United States
- Centralia, Illinois, United States
- Danville, Illinois, United States
- Decatur, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- Maywood, Illinois, United States
- O'Fallon, Illinois, United States
- Springfield, Illinois, United States
+ 83 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Irvine, California, United States; Coral Gables, Florida, United States; Coral Springs, Florida, United States; Deerfield Beach, Florida, United States; Doral, Florida, United States and 97 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.