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Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
A Phase II Study of Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
Ph+ leukemias (i.e.Chronic Myelogenous Leukemia (CML) and (Ph+) Acute Lymphoblastic Leukemia are malignant clonal disorder of the hemopoietic stem cell due to reciprocal translocation of genetic material between chromosome 9 and 22 giving rise to the translocation t(9;22) (q2.2; q2.1). The translocation causes the formation of a new hybrid gene (bcr-abl) that codes for a 185 kb or 210 kb cytoplasmic protein (P185 and P210 respectively) that by autophosphorylation activates a number of signaling pathways involved in cell proliferation, maturation, apoptosis and adhesion, leading to the malignant cell transformation1-3. The course of the disease goes on through a chronic phase (CP), usually lasting some years, that is characterized by a massive myeloid hyperplasia with hyperleukocytosis and splenomegaly. The CP is almost always followed by an accelerated or blastic phase (ABP) where the leukemic process acquires the characteristics of acute leukemia. The ABP usually lasts some months and terminates with the death of the patient3.
The frequency of CML in western countries ranges between 10 and 15 per million persons (age - standardized). It is rare in children. The median age is 55 years.
Current treatment of CML includes conventional chemotherapy, allogeneic bone marrow transplantation (allo BMT), alpha-interferon (alpha-IFN)and imatinib.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Bologna, Italië, 40138
- Policlinico "S.Orsola-Malpighi"-Istituto di Ematologia "L e A Seragnoli"
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria for chronic phase patients :
- Age >/=18 years
- Ph positive
- Absence of a CHR after 3 months on imatinib
- Loss of a previously obtained CHR on imatinib alone
- Absence of a CCgR within 12 months on imatinib alone
- Loss of a previously obtained CCgR on imatinib alone
- Written informed consent
Exclusion Criteria for chronic phase patients :
- Age <18
- Performance status (ECOG/WHO) > 2 (see Appendix 2)
- Inability to provide written informed consent
- Pregnancy
- Accelerated or blastic phase
- Formal refusal of any recommendation of a safe contraception
- Alcohol or drug addiction
- Altered hepatic or renal function as defined by AST/ALT or bilirubin > 3 times upper normal limits (UNL)
- Serum creatinine > 265 umol/l or >3.0 mg/dl
- Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
Inclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients:
- Age >/=18 years
- Ph positive
- Loss of a previous hematological response to imatinib alone, with further progression to ABP (see section 14 for definitions)
- Performance status (ECOG/WHO)
- Written informed consent
Exclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients:
- Age <18
- Performance status (ECOG/WHO) > 2 (see Appendix 2)
- Inability to provide written informed consent
- Pregnancy
- Chronic Phase disease
- Formal refusal of any recommendation of a safe contraception
- Alcohol or drug addiction
- Altered hepatic or renal function as defined by AST/ALT or bilirubin > 3 times upper normal limits (UNL)
- Serum creatinine > 265 umol/l or >3.0 mg/dl
- Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Giovanni Martinelli, MD, Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi di Bologna
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CML/033-26866138-CAN
- EUDRACT 2004-002977-22
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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