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Venetoclax; Rituximab

Phase 2

Waldenstrom Macroglobulinemia | Small molecule | Hematology |AbbVie Inc.|Last Updated: May 5, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Venetoclax; Rituximab · 1 trial · 2 indications

Phase 2 1
NCT05099471Efficacy of Venetoclax in Combination With Rituximab in Waldenström's MacroglobulinemiaWaldenstrom Macroglobulinemia
RECRUITING80 Analytics
PHASE2RECRUITING
Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia
Waldenstrom MacroglobulinemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of CR / VGPR
12 months

CR / VGPR 12 months after randomization

Secondary Endpoints

Interim reponse
12 months
Response rate
12 months
Best response
24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Venetoclax / RituximabEXPERIMENTALCycle 1 (28-days cycle) Stepwise dose escalation of Venetoclax in all patients with a target dose of xy mg/d QD PO. Day 1-7: Venetoclax xy mg/d QD PO Day 8-14: Venetoclax xy mg/d QD PO Day 15-28: Venetoclax xy mg/d QD PO Cycle 2-12: Day 1: Rituximab 375 mg/m2 IV Day 1-28: Venetoclax xy mg/d QD PO
Dexamethasone / Rituximab / CyclophosphamideACTIVE_COMPARATORCycle 1-6: Day 1: Dexamethasone 20 mg PO Day 1: Rituximab 375 mg/m2 IV Day 1-5: Cyclophosphamide 100 mg/m2 BID PO

Interventions

NameTypeDescription
Venetoclax; RituximabDRUGCombination of venetoclax and rituximab
DRCDRUGCombination of Dexamethasone / Rituximab / Cyclophosphamide
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM (IWWM). Histopathology has to be perfomed before randomization but within the last 4 months before start of treatment. In addition, pathological specimens ha...

Countries:GermanyGreece
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Frequently asked questions about Venetoclax; Rituximab

What is Venetoclax; Rituximab used for?

Venetoclax; Rituximab is being studied for the treatment of Waldenstrom Macroglobulinemia, specifically in treatment-naive patients. It is a combination therapy being evaluated in a Phase 2 clinical trial. The drug is intended for adult patients aged 18 years and older with this condition.

Who makes Venetoclax; Rituximab?

Venetoclax; Rituximab is being developed by AbbVie Inc. (ticker: ABBV). The company is conducting a Phase 2 clinical trial to evaluate the efficacy of this combination therapy in patients with Waldenstrom Macroglobulinemia.

What phase is Venetoclax; Rituximab in?

Venetoclax; Rituximab is currently in Phase 2 clinical development. It is an investigational combination therapy being studied for Waldenstrom Macroglobulinemia. The drug has not been approved and is still undergoing clinical trials to assess its efficacy and safety.

What clinical trials is Venetoclax; Rituximab in?

Venetoclax; Rituximab is being evaluated in a Phase 2 clinical trial with the identifier NCT05099471. This trial is titled 'Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia' and is currently recruiting participants in Germany and Greece.

Is Venetoclax; Rituximab the same as venetoclax and rituximab?

Venetoclax; Rituximab refers to the combination of venetoclax and rituximab used together in a single treatment regimen. The clinical trial NCT05099471 is studying this combination specifically for Waldenstrom Macroglobulinemia in treatment-naive patients.