SWOG clinical trial number
S2005
A Phase II Randomized Study of Ibrutinib and Rituximab with or without Venetoclax in Previously Untreated Waldenstrom's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Open
Phase
Accrual
2%
Abbreviated Title
A Phase II Randomized Study of Ibrutinib and Rituximab with or without Venetoclax in Previously Untreated Waldenstrom's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Status Notes
Re-Activation – Effective (9/20/2021)
Activated
06/24/2021
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Myeloma
Treatment
Rituximab
Ibrutinib
Venetoclax
Eligibility Criteria Expand/Collapse
Step 1: Initial Registration/Randomization
-Confirmed diagnosis of WM/LPL w/ measurable disease by IgM w/in 28 days prior to reg.
-At least one of the criteria to require therapy for WM.
-No strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inihibitor w/in 7 days prior to the first dose or planned ongoing use.
-No prior systemic therapy. (except rituximab if last dose was at least 12 months prior to reg).
->/= 18 years.
-History and physical w/in 28 days prior to reg.
-Zubrod Performance Status </= 2.
-Not intolerant to rituximab.
-Creatinine clearance (CrCl) >/= 30 mL/min w/in14 days prior to reg.
-No hepatic dysfunction w/in 14 days prior to reg.
-Adequate bone marrow function w/out transfusion or growth factors w/in 14 days prior to reg (platelets >/= 50,000, hemoglobin >/= 7.0, ANC >/= 1,000)
-No active infection at study reg, or any major infection requiring IV antibiotics or hospitalization w/in 4 weeks prior to reg.
-HIV+: must be on effective anti-retroviral therapy and have undetectable viral load at most recent viral load test and w/in 6 months prior to reg
-No hepatitis C (except sustained virologic response
-Must be able to take and swallow oral meds. No known impairment of GI function or GI disease that may significantly alter the absorption of the study drug.
-No grapefruit, Seville oranges or starfruit w/in 3 days prior to the first dose of venetoclax.
-Must not be pregnant or nursing.
-No other prior malignancy (see exceptions)
-Must be offered specimen banking participation.
Step 2: Crossover
-Must have been registered and received treatment in the IR arm, and must show progression of disease during Cycles 3-24.
-No transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome.
-Zubrod Performance Status </= 2 .
-Creatinine clearance (CrCl) >/= 30 mL/min w/in 14 days prior to reg.
-No hepatic dysfunction w/in 14 days prior to reg.
-Adequate bone marrow function w/out transfusion or growth factors w/in 14 days prior to reg (platelets >/= 50,000, hemoglobin >/= 8.0, ANC >/= 1,000)
-Confirmed diagnosis of WM/LPL w/ measurable disease by IgM w/in 28 days prior to reg.
-At least one of the criteria to require therapy for WM.
-No strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inihibitor w/in 7 days prior to the first dose or planned ongoing use.
-No prior systemic therapy. (except rituximab if last dose was at least 12 months prior to reg).
->/= 18 years.
-History and physical w/in 28 days prior to reg.
-Zubrod Performance Status </= 2.
-Not intolerant to rituximab.
-Creatinine clearance (CrCl) >/= 30 mL/min w/in14 days prior to reg.
-No hepatic dysfunction w/in 14 days prior to reg.
-Adequate bone marrow function w/out transfusion or growth factors w/in 14 days prior to reg (platelets >/= 50,000, hemoglobin >/= 7.0, ANC >/= 1,000)
-No active infection at study reg, or any major infection requiring IV antibiotics or hospitalization w/in 4 weeks prior to reg.
-HIV+: must be on effective anti-retroviral therapy and have undetectable viral load at most recent viral load test and w/in 6 months prior to reg
-No hepatitis C (except sustained virologic response
-Must be able to take and swallow oral meds. No known impairment of GI function or GI disease that may significantly alter the absorption of the study drug.
-No grapefruit, Seville oranges or starfruit w/in 3 days prior to the first dose of venetoclax.
-Must not be pregnant or nursing.
-No other prior malignancy (see exceptions)
-Must be offered specimen banking participation.
Step 2: Crossover
-Must have been registered and received treatment in the IR arm, and must show progression of disease during Cycles 3-24.
-No transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome.
-Zubrod Performance Status </= 2 .
-Creatinine clearance (CrCl) >/= 30 mL/min w/in 14 days prior to reg.
-No hepatic dysfunction w/in 14 days prior to reg.
-Adequate bone marrow function w/out transfusion or growth factors w/in 14 days prior to reg (platelets >/= 50,000, hemoglobin >/= 8.0, ANC >/= 1,000)
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SWOG Clinical Trial Number
S2005
A Phase II Randomized Study of Ibrutinib and Rituximab with or without Venetoclax in Previously Untreated Waldenstrom's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Research Committee(s)
Myeloma
Activated
06/24/2021
Accrual
2%
Open
Phase