Kompetenznetz "Akute und chronische Leukämien"

Kompetenznetz "Akute und chronische Leukämien"
SHORTPROTOCOL
ALL GIMEMA 0904
Public Title
Treatment of high-risk ALL and MRD-monitoring
Scientific Title
Intensification of post-remissional treatment of high-risk acute lymphoblastic leukemia in
adults and minimal residual disease monitoring
Short Title
ALL GIMEMA 0904
Id KN/ELN
LN_MDSIG_2005_112
Trialgoup
MDS-IG
Type of Trial
multicentric, prospective, open-label
Phase
Phase II
Disease
Acute lymphoblastic leukemia( ALL) All subtypes
Stage of Disease
de novo/non-treated
Inclusion Criteria
-
Negative myeloperoxidase stain
-
Phenotype T (T-ALL) or B (B-ALL)
-
No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl
transferase-negative)
-
prior steroids
-
prior antiblastic chemotherapy
-
mature LAL-B (FAB L3, sIg+, TdT-)
-
Creatinine > 2.5 mg/dL (after adequate hydration)
-
SGOT and SGPT >3 times upper limit of normal
-
LVEF >= 50%
-
severe psychiatric disorders
-
other concurrent malignant disease
-
presence of documented infections not responding to antibiotic and/or antifungal
therapy
Exclusion Criteria
Age
<= 60 years
Status
No longer recruiting
start of Recruitment
04.07.2005
Target Sample Size
470
Leader
Foà, Prof. Dr. med., Robin
University "La Sapienza"
Division of Hematology
Via Benevento 6
00161 Rom
Tel: +39 (0)6 85795253
Fax: +39 (0)6 85795292
Email: [email protected]
Scientific Contact (WHO)
Foà, Prof. Dr. med., Robin
University "La Sapienza"
Division of Hematology
Via Benevento 6
00161 Rom
Tel: +39 (0)6 85795253
Fax: +39 (0)6 85795292
Email: [email protected]
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 21.11.2016; page 1 of 2
Kompetenznetz "Akute und chronische Leukämien"
SHORTPROTOCOL
ALL GIMEMA 0904
Contact Person
General Contact Person
Vignetti, Dr. med., Marco
Tel: +39 (0)6 44163 9831
Fax: +39 (0)6 440 2516
Email: [email protected]
General Contact Person
Meloni, Prof. Dr. med., Giovanna
Tel: +39 (0)6 -85795273
Fax: +39 (0)6 -44241984
Email: [email protected]
Centre of Trial
University "La Sapienza" Rome; Italy
Sponsors
GIMEMA Foundation
Other Registers
ClinicalTrials.govNCT00458848 (Primary Register)
European Clinical Trials Database - EUDRACT2004-001738-17
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 21.11.2016; page 2 of 2

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