Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Summary
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
Timeline
- Start
- 2008-12-22
- Primary completion
- 2013-03-20
- Completion
- 2018-05-17
Outcome
Met primary endpoint
Stopped: “Majority of patients (62%) had been treated with next line therapies, including new highly effective therapies confounding the interpretation of the OS results.”
paper hazard ratio 0·57, 95% CI 0·45-0·72; p<0·0001 PMID 25882396 ↗
release “in combination with chlorambucil versus chlorambucil alone in patients with previously untreated chronic lymphocytic leukaemia (CLL) met its primary endpoint of progression free survival (PFS)” gsk.com ↗
release “Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival (PFS).” gsk.com ↗
release “Arzerra ® (ofatumumab) plus chlorambucil, a chemotherapy, resulted in a statistically significant improvement in progression free survival (PFS)” novartis.com ↗
Publications
- Tausch E, Beck P, Schlenk RF, Jebaraj BJ, Dolnik A, Yosifov DY, Hillmen P, Offner F, Janssens A, Babu GK, Grosicki S, Mayer J, Panagiotidis P, McKeown A, Gupta IV, Skorupa A, Pallaud C, Bullinger L, Mertens D, Dohner H, Stilgenbauer S. Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1. Haematologica. 2020 Oct 1;105(10):2440-2447. doi: 10.3324/haematol.2019.229161.
- Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S, Doubek M, Panagiotidis P, Kimby E, Schuh A, Pettitt AR, Boyd T, Montillo M, Gupta IV, Wright O, Dixon I, Carey JL, Chang CN, Lisby S, McKeown A, Offner F; COMPLEMENT 1 Study Investigators. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015 May 9;385(9980):1873-83. doi: 10.1016/S0140-6736(15)60027-7. Epub 2015 Apr 14.
- Jewell RC, Laubscher K, Lewis E, Fang L, Gafoor Z, Carey J, McKeown A, West S, Wright O, Sedoti D, Dixon I, Hottenstein CS, Chan G. Assessment of the effect of ofatumumab on cardiac repolarization. J Clin Pharmacol. 2015 Jan;55(1):114-21. doi: 10.1002/jcph.376. Epub 2014 Aug 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Chlorambucil | Other / unclassified | 10 mg/m2 | Oral |