Comparison of Cladribine+Cyclophosphamide with Fludarabine+Cyclophosphamide

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[2826] Randomized Comparison of Cladribine Plus Cyclophsophamide with

Fludarabine Plus Cyclophosphamide in Progressive Chronic Lymphocytic

Leukemia: An Updated Report of Prospective PALG-CLL3 Study. Session

Type: Poster Session, Board #55-III

Tadeusz Robak, Jerzy Z. Blonski, Joanna Gora-Tybor, Krzysztof

Jamroziak, Bernadetta Ceglarek, Lech Konopka, Malgorzata Calbecka,

Aleksandra Kostyra, Beata Stella-Holowiecka, Janusz Kloczko,

Krzysztof Warzocha, Ilona Seferynska, Dmoszynska, Malgorzata

Kowal, Krzysztof Lewandowski, Jadwiga Dwilewicz-Trojaczek, Elzbieta

Wiater, Stanislaw Potoczek, Andrzej Hellmann, Aleksander Skotnicki,

Kazimierz Sulek, Jacek Dybowicz, Krystyna Zawilska Department of

Hematology, Medical University of Lodz, Lodz, Poland; Polish Adult

Leukemia Group (PALGCLL3), Poland

Purine analogues, Cladribine (2-CdA) and Fludarabine (FA), are highly

effective in treatment of chronic lymphocytic leukemia (CLL).

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. 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/m2/d i.v. for 3

consecutive days or FA 25 mg/m2/d i.v. with cyclophosphamide 250

mg/m2/d i.v. for 3 consecutive days administered at 28 day intervals.

The treatment response and toxicity were evaluated according to NCI-

SWOG guidelines.

The study started in January 2004, and here we present updated

results from the interim analysis of 227 evaluated patients performed

in July 2006.

As shown in the table, there were no significant differences in the

rates of CR and OR between the treatment groups. Moreover, the

treatment related toxicity, including grade thrombocytopenia,

neutroepenia and infections was similar in patients receiving FC or

CC regimens.

Median time of progression free survival did not differ between both

groups (11.0 months in CC arm and 11.2 months in FC arm, p=0.41).

There were 5 deaths (3.2%) observed in CC arm and 15 (8.1%) in FC

arm.

In conclusion, the preliminary results of our study indicate that CC

and FC protocols have similar activity and toxicity in previously

untreated patients with CLL.

Supported by grant 2P05B01828 from Ministry of Science, Warsaw,

Poland.