Title | The value of autografting in patients with high-risk chronic lymphocytic leukemia. A randomized phase III intergroup trial |
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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 |
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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 |