DCLLSG

CLL3X Trial

Title Pilot study on allogeneic stem cell transplantation following conditioning with fludarabine and an alkylating agent in patients with high-risk chronic lymphocytic leukemia
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