12th Congress of the European Hematology ... - Haematologica

ure 1). Conclusions. Results for reduced-intensity allogeneic transplantation
are promising for selected patients with poor prognosis CLL. There
is, however, insufficient data at this point in time to recommend the
procedure outside clinical trials. International multicentre studies with
greater numbers of patients could help clarify this issue.
Figure 1. Overall survival according to therapy.
0120
PHASE III STUDY OF CLADRIBINE PLUS CYCLOPHOSPHAMIDE COMPARED WITH FLU-
DARABINE PLUS CYCLOPHOSPHAMIDE FOR PATIENTS WITH PROGRESSIVE CHRONIC
LYMPHOCYTIC LEUKEMIA: REPORT OF PALGCLL3 TRIAL
T. Robak, 1 J.Z. Blonski, 1 J. Gora-Tybor, 1 K. Jamroziak, 1 B. Ceglarek, 2
L. Konopka, 2 M. Calbecka, 2 A. Kostyra, 2 B. Stella-Holowiecka, 2
J. Kloczko, 2 K. Warzocha, 2 I. Seferynska, 2 A. Dmoszynska, 2 M. Kowal, 2
K. Lewandowski, 2 J. Dwilewicz-Trojaczek, 2 G. Charlinski, 2
K. Kuliczkowski, 2 S. Potoczek, 2 A. Hellmann, 2 A. Mital, 2 A. Skotnicki, 2
W.S. Nowak, 2 A. Zdunczyk, 2 J. Dybowicz, 2 K. Sulek, 2 K. Zawilska2 1 2 Medical University of Lodz LODZ; Polish Adult Leukemia Group, (PAL-
GCLL3), Poland
Background. Purine analogues, Cladribine (2-CdA) and Fludarabine
(FA), are highly effective in treatment of chronic lymphocytic leukemia
(CLL). Patients and Methods. This prospective randomized phase 3 trial
was designed to compare the efficacy and toxicity of 2-CdA and
cyclophsophamide (CC regimen) with FA and cyclophsophamide (FC
regimen) in previously untreated progressive CLL. The primary end
points of the study were complete response (CR) and overall response
(OR) after completion of the therapy.
Table 1.
The secondary end points were progression free survival (PFS), overall
survival (OS) and treatment related toxicity. Eligible patients were
assigned to receive 6 courses of either 2-CdA 0.12 mg/kg/d i.v. with
cyclophosphamide 250 mg/m 2 /d i.v. for 3 consecutive days or FA 25
mg/m 2 /d i.v. with cyclophosphamide 250 mg/m 2 /d i.v. for 3 consecutive
days administered at 28 day intervals. The treatment response and toxicity
were evaluated according to NCI-SWOG guidelines. Minimall residual
disease (MRD) was evaluated in patients with CR using three-color
cytometry. Results. The study was started in January 2001 and here we
present updated results from the 296 evaluated patients performed in
December 2006. There were no significant differences in the rates of
overall response (OR), complete response (CR), grade 3/4 neutropenia,
thrombocytopenia and infections, MRD negativity and number of died
patients. PFS was also similar in both groups (p=0.77). Conclusions. CC
and FC regimens produced similar CR, OR and PFS, as well as have similar
toxicity in previously untreated, progressive CLL.
Supported by Grant 2P05B01828 from Ministry of Science, Warsaw, Poland
0121
IMMUNE THROMBOCYTOPENIA IMPAIRS SURVIVAL OF PATIENTS WITH CHRONIC
LYMPHOCYTIC LEUKEMIA
C.V. Visco, 1 R. Stasi, 2 M. Ruggeri, 1 F. Frattini, 3 R Zanotti, 3
A. Ambrosetti, 3 S. Fortuna, 1 I. Giaretta, 1 D. Madeo, 1 G. Pizzolo, 3
F. Rodeghiero1 1 Ospedale S Bortolo, VICENZA; 2 Ospedale Regina Apostolorum, ALBANO
LAZIALE; 3 Policlinico GB Rossi, VERONA, Italy
Background. Immune thrombocytopenia (IT) is the most frequent
autoimmune disorder during CLL, second only to hemolytic anemia.
However, the real prevalence and the natural history of this complication
are largely unknown. Aims. To determine main clinical features and
overall survival (OS) of patients developing IT in the course of CLL.
Methods. We retrospectively analyzed clinical records of 1233 consecutive
patients with CLL admitted for the first time to three tertiary hematological
center between 1 January 1995 and 31 December 2004. All
patients met the diagnostic criteria for CLL of the National Cancer Institute.
To be considered as affected by IT, patients had to fulfill the following
criteria: rapid (90%) lymphoid
infiltration; no or limited splenomegaly; no recent (less than one
month) cytotoxic treatment. Complete response (CR) to treatment for
IT was defined by a platelet count ≥150×10 9 /L, while partial response
(PR) by a platelet count > 50×10 9 /L or at least doubling the initial level.
Remaining patients were considered as no responders (NR). Results. Sixty-four
patients (5,1%) had IT at presentation or developed it during the
course of the disease. IT could be established concomitantly to CLL diagnosis
in 14 cases, while median time to IT for the remaining 50 patients
was 30 months (range 2-117). The median platelet count at IT diagnosis
was 14×10 9 /L (range, 1-71). Twenty-six patients (41%) presented with
moderate bleeding signs at IT diagnosis, with 5 patients (8%) experiencing
severe hemorrhagic episodes. Fifty-six of the 64 patients (87%)
received at least one treatment for IT.
Figure 1.
12 th Congress of the European Hematology Association
Of the 33 patients who received i.v. Ig alone or in combination with
steroids, 39% had at least a PR; 10 patients underwent splenectomy and
7 (70%) experienced a durable CR; 73% of patients who were treated
with chemotherapy (Chlorambucil, COP, CVP) ± steroids obtained at
least a PR. Two spontaneous remissions were observed. With a median
follow-up of 63 months from IT onset 16 of the 56 treated patients are
still NR (29%) and 13 of them still require treatment. No significant clinical
differences were observed at CLL presentation between patients
haematologica/the hematology journal | 2007; 92(s1) | 43