CLL2H Trial

Title Subcutaneous Campath-1H (Alemtuzumab; MabCampath®) in fludarabine-refractory CLL
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,
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
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
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