Title | Subcutaneous Campath-1H (Alemtuzumab; MabCampath®) in fludarabine-refractory CLL |
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Protocol IDs | |
Recruitment Status | closed |
Design | Prospective, open-label, multicentre, phase II trial |
Objective(s) | Has the subcutaneous administration of alemtuzumab similar efficacy
compared to intravenous administration, without the first-dose
infusion-related side effects ? Can subcutaneous alemtuzumab elicit responses in patients with high-risk genetic abnormalities (unmutated IgV H, del [17p], del [11q]) who have progressed on fludarabine therapy? |
Study Population | B-CLL, Binet-Stage C or A/B with need for treatment, F-refractory max 5 prior chemotherapies Age ≥ 18 years |
Treatment | Dose escalation: Alemtuzumab s.c. 3, 10, 30mg daily for 1-2 weeks + Pegfilgrastim (Neulasta®) s.c. 6 mg forthightly Therapy: Alemtuzumab s.c. 3x 30mg/week (d1+3+5), max 12 weeks --> SD or PD (optional): Alemtuzumab s.c. (max 12 weeks) + F (25 mg/m2) + C (200 mg/m2), d1+3, q28d, max 3 cycles |
Patients recruited | 109 patients |
Time schedule | study start: 09/2002 recruitment period: 18.09.2002 - 02.02.2006 |
Principal investigator(s) | PD Dr. S. Stilgenbauer, University of Ulm |
Publication(s) | Schnaiter A, Paschka P, Rossi M, Zenz T, Bühler A, Winkler D, Cazzola M, Döhner K, Edelmann J, Mertens D, Kless S, Mack S, Busch R, Hallek M, Döhner H, Stilgenbauer S NOTCH1, SF3B1 and TP53 mutations in fludarabine-refractory CLL patients treated with alemtuzumab: results from the CLL2H trial of the GCLLSG Blood. 2013 Jul 2. [Epub ahead of print] |
Zenz T, Häbe S, Denzel T, Mohr J, Winkler D, Bühler A, Sarno A,
Groner S, Mertens D, Busch R, Hallek M, Döhner H, Stilgenbauer S Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial Blood. 2009 Sep 24;114(13):2589-97 |
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Stilgenbauer S, Zenz T, Winkler D, Bühler A, Schlenk RF, Groner S,
Busch R, Hensel M, Dührsen U, Finke J, Dreger P, Jäger U, Lengfelder E,
Hohloch K, Söling U, Schlag R, Kneba M, Hallek M, Döhner H; German
Chronic Lymphocytic Leukemia Study Group Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group J Clin Oncol. 2009 Aug 20;27(24):3994-4001 |