Title | Pilot study on allogeneic stem cell transplantation following conditioning with fludarabine and an alkylating agent in patients with high-risk chronic lymphocytic leukemia |
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Protocol IDs | NCT00281983 |
Participating Countries | Germany |
Status | completed |
Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
Design | Prospective, open-label, multicentre, phase I/II trial |
Primary Objective(s) | Feasibility and safety of allogeneic PBSCT following conditioning with fludarabine and an alkylating agent in patients with high-risk CLL or lymphoplasmocytic lymphoma (Waldenström's macroglobulinemia) |
Secondary Endpoints | - Incidence and the kinetics of clinical and molecular remissions post allogeneic SCT - Event-free survival, overall survival - Duration of clinical and molecular remission in relation to cytogenetic deviation - Kinetics and extent of lymphohematopoietic donor chimerism after allogeneic SCT following fludarabine/alkylating agent |
Study Population | High-risk B-CLL, Binet-Stage C, B with poor prognostic features or Waldenström's
macroglobulinemia Age ≥ 18 to ≤ 65 years |
Treatment | 1. Cytoreductive therapy (--> PR): FC or FC-R or alternative salvage regimens (z.B. Alemtuzumab) 2. Conditioning regimen: FC +/- ATG (Arm A) or FC/Busulfan +/- ATG (Arm C: refractory patients only) 3. allogeneic-PBSCT (from HLA-identical donor) 4. GVHD prophylaxis: CSA + MTX or MMF 5. +/- DLI (Donor lymphocyte infusions) |
Patients recruited | 100 patients |
Time schedule | recruitment period: 20.06.2001 - 23.03.2007 End of study: Oct 2007 Clinical Study Report / Publication: July 2008 End of archiving period:Oct 2022 |
Sponsor | DCLLSG/Heidelberg/Dreger with Canadian participation |
Principal investigator(s) | PD Dr. P. Dreger, University of Heidelberg Prof. Dr. H. Döhner, University of Ulm |
Publication(s) | Krämer I, Stilgenbauer S, Dietrich S, Böttcher S, Zeis M, Stadler M, Bittenbring J, Uharek L, Scheid C, Hegenbart U, Ho A, Hallek M, Kneba M, Schmitz N, Döhner H, Dreger P Allogeneic hematopoietic cell transplantation for high-risk CLL: 10-year follow-up of the GCLLSG CLL3X trial Blood. 2017 Jul 17. pii: blood-2017-04-775841 [Epub ahead of print] Scheffold A, Jebaraj BM, Jaramillo S, Tausch E, Steinbrecher D, Hahn M, Böttcher S, Ritgen M, Bunjes D, Zeis M, Stadler M, Uharek L, Scheid C, Hegenbart U, Hallek M, Kneba M, Schmitz N, Döhner H, Dreger P, Stilgenbauer S Impact of telomere length on the outcome of allogeneic stem cell transplantation for poor-risk chronic lymphocytic leukaemia: results from the GCLLSG CLL3X trial Br J Haematol. 2016 Jul 8 [Epub ahead of print] Dreger P, Schnaiter A, Zenz T, Böttcher S, Rossi M, Paschka P, Bühler A, Dietrich S, Busch R, Ritgen M, Bunjes D, Zeis M, Stadler M, Uharek L, Scheid C, Hegenbart U, Hallek M, Kneba M, Schmitz N, Döhner H, Stilgenbauer S TP53, SF3B1, and NOTCH1 mutations and outcome of allotransplantation for chronic lymphocytic leukemia: six-year follow-up of the GCLLSG CLL3X trial Blood. 2013 Feb 22. [Epub ahead of print] Dreger P, Döhner H, Ritgen M, Böttcher S, Busch R, Dietrich S, Bunjes D, Cohen S, Schubert J, Hegenbart U, Beelen D, Zeis M, Stadler M, Hasenkamp J, Uharek L, Scheid C, Humpe A, Zenz T, Winkler D, Hallek M, Kneba M, Schmitz N, Stilgenbauer S. Allogeneic stem cell transplantation provides durable disease control in poor-risk chronic lymphocytic leukemia: long-term clinical and MRD results of the GCLLSG CLL3X trial Blood. 2010 Oct 7;116(14):2438-47 Ritgen M, Böttcher S, Stilgenbauer S, Bunjes D, Schubert J, Cohen S, Humpe A, Hallek M, Kneba M, Schmitz N, Döhner H, Dreger P; German CLL Study Group Quantitative MRD monitoring identifies distinct GVL response patterns after allogeneic stem cell transplantation for chronic lymphocytic leukemia: results from the GCLLSG CLL3X trial Leukemia. 2008 Jul;22(7):1377-86 |