DCLLSG

CLL3R Trial

Title The value of autografting in patients with high-risk chronic lymphocytic leukemia. A randomized phase III intergroup trial
Protocol IDs MRC CLL5
ISRCTN69559570
Recruitment Status prematurely terminated due to slow recruitment
Design Prospective, open-label, randomised, multicentre, phase III trial
Primary Endpoint(s) Event-free survival (EFS) from randomisation
Secondary Endpoint(s) Overall survival from randomisation, time to disease-requiring therapy from time of remission (Treatment-free survival – TFS), quality of life analysis (QOL), toxicity and feasibility of 1st line versus later SCT, quantitative analysis and prognostic impact of molecular response, prognostic impact of cytogenetics and mutational status, comparison to historical controls (CLL3 study and CLL6 study)
Study Population Symptomatic B-CLL, Binet-Stage C, B or A progressive,
in remission after arbitrary standard chemotherapy
Age  ≥ 18 to ≤ 65 years
Treatment Treatment Arm 0 (w&w):
1. Arbitrary standard chemotherapy --> Remission
2. Mobilization: CY3+G-CSF
Treatment Arm 1 (ASCT):
1. Arbitrary standard chemotherapy --> Remission
2. Mobilization: Dexa-BEAM + G-CSF
3. Conditioning (TBI/C)
4. Autografting
Patients recruited 223 patients (36 patients from Germany)
Time schedule study start: 18.10.2001
recruitment period (Germany): 02.07.2002 - 18.07.2007
Protocol Version 21.05.2001 Protocol
Sponsor Primary Sponsors: EBMT, Heart of England NHS Foundation Trust (UK)
Secondary Sponsors: MRC (UK), GCLLSG (Germany), SAKK (Switzerland), SFGM (France)
Principal investigator(s) PD Dr. P. Dreger, University of Heidelberg
Dr. M. Michallet, Hopital Eduard Herriot, Lyon (F)
Documents
(publicly available)
Flowchart
Publications Michallet M, Dreger P, Sutton L, Brand R, Richards S, van Os M, Sobh M, Choquet S, Corront B, Dearden C, Gratwohl A, Herr W, Catovsky D, Hallek M, de Witte T, Niederwieser D, Leporrier M, Milligan D
Autologous hematopoietic stem cell transplantation in chronic lymphocytic leukemia: results of European intergroup randomized trial comparing autografting versus observation
Blood. 2011 Feb 3;117(5):1516-21