Kurzprotokoll - Kompetenznetz Leukämie

Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
ALL Forodesin bei B-Vorläufer ALL
Öffentlicher Titel
Forodesine Hydrochloride Infusion in Patients with B-cell Acute Lymphoblastic Leukemia
Kurztitel
ALL Forodesin bei B-Vorläufer ALL
Studiennummer KN/ELN
LN_GMALL_2006_165
Studiengruppe
GMALL
Studienart
multizentrisch, offen
Studienphase
Phase I/II
Erkrankung
Akute lymphatische Leukämie (ALL) - B-Vorläufer ALL
Leukämiestadium
rezidiviert/refraktär
Ziele
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To determine the safety of repeat doses of intravenous (IV) forodesine in patients
with B-cell acute lymphoblastic leukemia (B-ALL), which under World Health
Organization (WHO) Guidelines is now referred to as precursor B-lymphoblastic
leukemia/lymphoma
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To describe the steady-state pharmacokinetics (PK) of forodesine following repeat
administration
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To evaluate the pharmacodynamic (PD) effects of forodesine on plasma levels of 2deoxyguanosine (dGuo) and red blood cell (RBC) purine nucleoside phosphorylase
(PNP) activity and to correlate levels with efficacy parameters
-
To determine the efficacy of repeat doses of IV forodesine, as evidenced by
peripheral blood and bone-marrow (BM) evaluations
-
To evaluate the maintenance of response and safety of forodesine with extended
treatment
-
Documented B-cell acute lymphoblastic leukemia (B-ALL), which under WHO
Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
-
Must have failed at least 1 treatment regimen for B-ALL, which under WHO
Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
-
Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria
(see Appendix A)
-
Any age is allowed
-
Life expectancy of at least 3 months
-
Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase
[ALT] not >3 times upper limits of normal [ULN])
-
Adequate kidney function (calculated creatinine clearance >40 mL/min)
-
Negative serum or urine pregnancy test within 2 to 7 days prior to the start of study
treatment in females of childbearing potential
-
Females of childbearing potential and males must be willing and able to use an
adequate method of contraception to avoid pregnancy for the duration of the study in
such a manner that the risk of pregnancy is minimized. Acceptable contraceptives
include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or
injectable) and double barrier methods such as condoms or diaphragms with
spermicidal gel or foam.
-
Signed informed consent form (ICF), minor assent form (if applicable), prior to start of
any study-specific procedures
-
Active serious infection not controlled by oral or intravenous antibiotics
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Treatment with any investigational antileukemic agent or chemotherapy agent in the
last 7 days prior to study entry and lack of full recovery from side effects due to prior
therapy independent of when that therapy was given
-
Rapidly progressive disease with compromised organ function judged to be lifethreatening by the Investigator
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Patients with clinical evidence of active central nervous system (CNS) disease
Einschlusskriterien
Ausschlusskriterien
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 20.01.2017; Seite 1 von 2
Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
ALL Forodesin bei B-Vorläufer ALL
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Concurrent treatment with other anticancer agents
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Pregnant and/or lactating female
-
Patients with known human immunodeficiency virus (HIV) infection; HIV testing will
be performed at the Screening visit for patients who have not been tested within 6
months of receiving study drug, as well as those patients who have had exposure or
have been transfused with blood products that were not appropriately screened.
-
Patients with known active hepatitis B and/or hepatitis C infection;Hepatitis testing will
be performed at the Screening visit for patients who have not been tested within 6
months of receiving study drug, as well as those patients who have had exposure or
have been transfused with blood products that were not appropriately screened.
-
Hypersensitive or intolerant to any component of the study drug formulation
Alter
Alle Altersgruppen
Status
Geschlossen
Beginn der Rekrutierung
01.01.2006
Rekrutierende Länder
Deutschland
U.S.A
Fallzahl
20
Studienleiter/in
Hoelzer, Prof. Dr. med., Dieter
ONKOLOGIKUM Frankfurt am Museumsufer
Schaubstr.16
60596 Frankfurt / Main
Tel: +49 (0)69 650073170
Fax: +49 (0)69 650073180
E-Mail: [email protected]
Kontaktperson f.
wissenschaftl. Anfragen
(WHO)
Hoelzer, Prof. Dr. med., Dieter
ONKOLOGIKUM Frankfurt am Museumsufer
Schaubstr.16
60596 Frankfurt / Main
Tel: +49 (0)69 650073170
Fax: +49 (0)69 650073180
E-Mail: [email protected]
Studienzentrale
Universitätsklinikum Frankfurt
Sponsoren
BioCryst Pharmaceuticals, Inc. (BioCryst)
Förderer
BioCryst Pharmaceuticals, Inc. (BioCryst)
2190 Parkway Lake Drive
AL 35244 Birmingham
Tel: +44 (0)205 444-4600
Fax: +44 (0)205 444-4640
E-Mail: [email protected]
Homepage: www.biocryst.com/
Registrierung in anderen
Studienregistern
ClinicalTrials.govNCT00289562 (primäres Register)
BioCryst Pharmaceuticals, Inc. (BioCryst)BCX1777-Bi-04-106
Studientherapie
-
name
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 20.01.2017; Seite 2 von 2