# Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

> **NCT00748189** · PHASE3 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 447 (actual)

## Conditions studied

- Leukaemia, Lymphocytic, Chronic

## Interventions

- **DRUG:** chlorambucil, tablets
- **DRUG:** ofatumumab (GSK1841157) infusion

## Key facts

- **NCT ID:** NCT00748189
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2008-12-22
- **Primary completion:** 2013-03-20
- **Final completion:** 2018-05-17
- **Target enrollment:** 447 (ACTUAL)
- **Why stopped:** Majority of patients (62%) had been treated with next line therapies, including new highly effective therapies confounding the interpretation of the OS results.
- **Last updated:** 2019-06-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00748189

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00748189, "Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT00748189. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*