SWOG clinical trial number
S2005
A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Open
Phase
Accrual
17%
Abbreviated Title
A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Status Notes
Re-Activation - Effective (2/15/2024)
Activated
06/24/2021
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Myeloma
Treatment
Rituximab
Ibrutinib
Venetoclax
Patient Study Materials
Patient Clinical Trial Summary
Download PDF of Patient Clinical Trial Summary
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 COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Research Committee(s)
Myeloma
Activated
06/24/2021
Accrual
17%
Open
Phase