Cladribine + Cytoxan Compared with Fludara + Cytoxan Gives Equal Response

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PHASE III STUDY OF CLADRIBINE PLUS CYCLOPHOSPHAMIDE COMPARED WITH

FLUDARABINE PLUS CYCLOPHOSPHAMIDE FOR PATIENTS WITH PROGRESSIVE

CHRONIC LYMPHOCYTIC LEUKEMIA: REPORT OF PALGCLL3 TRIAL

0120

Author Robak, Tadeusz , Lodz, Medical University of Lodz Poland

Co-author(s) Blonski, Jerzy Z. , Lodz, Medical University of Lodz

Gora-Tybor, Joanna , Lodz, Medical University of Lodz

Jamroziak, Krzysztof , Lodz, Medical University of Lodz

Ceglarek, Bernadetta , (PALGCLL3), Polish Adult Leukemia Group

Konopka, Lech , (PALGCLL3), Polish Adult Leukemia Group

Calbecka, Malgorzata , (PALGCLL3), Polish Adult Leukemia Group

Kostyra, Aleksandra , (PALGCLL3), Polish Adult Leukemia Group

Stella-Holowiecka, Beata , (PALGCLL3), Polish Adult Leukemia Group

Kloczko, Janusz , (PALGCLL3), Polish Adult Leukemia Group

Warzocha, Krzysztof , (PALGCLL3), Polish Adult Leukemia Group

Seferynska, Ilona , (PALGCLL3), Polish Adult Leukemia Group

Dmoszynska, , (PALGCLL3), Polish Adult Leukemia Group

Kowal, Malgorzata , (PALGCLL3), Polish Adult Leukemia Group

Lewandowski, Krzysztof , (PALGCLL3), Polish Adult Leukemia Group

Dwilewicz-Trojaczek, Jadwiga , (PALGCLL3), Polish Adult Leukemia

Group

Charlinski, Grzegorz , (PALGCLL3), Polish Adult Leukemia Group

Kuliczkowski, Kazimierz , (PALGCLL3), Polish Adult Leukemia Group

Potoczek, Stanislaw , (PALGCLL3), Polish Adult Leukemia Group

Hellmann, Andrzej , (PALGCLL3), Polish Adult Leukemia Group

Mital, Andrzej , (PALGCLL3), Polish Adult Leukemia Group

Skotnicki, Aleksander , (PALGCLL3), Polish Adult Leukemia Group

Nowak, Wies³aw S , (PALGCLL3), Polish Adult Leukemia Group

Zdunczyk, Andrzej , (PALGCLL3), Polish Adult Leukemia Group

Dybowicz, Jacek , (PALGCLL3), Polish Adult Leukemia Group

Sulek, Kazimierz , (PALGCLL3), Polish Adult Leukemia Group

Zawilska, Krystyna , (PALGCLL3), Polish Adult Leukemia Group

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. 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. 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).

Conclusion: 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