# A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations

> **NCT03226301** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Stichting Hemato-Oncologie voor Volwassenen Nederland** · enrollment: 230 (estimated)

## Conditions studied

- Chronic Lymphocytic Leukemia in Relapse
- Chronic Lymphocytic Leukemia in Remission

## Interventions

- **DRUG:** Ibrutinib + Venetoclax 15 cycles
- **DRUG:** Ibrutinib until progression/relapse
- **DRUG:** Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles

## Key facts

- **NCT ID:** NCT03226301
- **Lead sponsor:** Stichting Hemato-Oncologie voor Volwassenen Nederland
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2017-06-23
- **Primary completion:** 2021-06-30
- **Final completion:** 2026-06-21
- **Target enrollment:** 230 (ESTIMATED)
- **Last updated:** 2022-08-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03226301

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03226301, "A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT03226301. Licensed CC0.

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