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Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia

Descriptive Information
Brief Title † Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
Official Title † A Phase II Study of Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
Brief Summary 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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Leukemia
Intervention † DrugBortezomib
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 3
Start Date † July 2006
Completion Date February 2008
Primary Completion Date February 2008
Eligibility Criteria † Inclusion Criteria for chronic phase patients : 1. Age >/=18 years 2. Ph positive 3. Absence of a CHR after 3 months on imatinib 4. Loss of a previously obtained CHR on imatinib alone 5. Absence of a CCgR within 12 months on imatinib alone 6. Loss of a previously obtained CCgR on imatinib alone 7. Written informed consent Exclusion Criteria for chronic phase patients : 1. Age 2 (see Appendix 2) 3. Inability to provide written informed consent 4. Pregnancy 5. Accelerated or blastic phase 6. Formal refusal of any recommendation of a safe contraception 7. Alcohol or drug addiction 8. Altered hepatic or renal function as defined by AST/ALT or bilirubin > 3 times upper normal limits (UNL) 9. Serum creatinine > 265 umol/l or >3.0 mg/dl 10. 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: 1. Age >/=18 years 2. Ph positive 3. Loss of a previous hematological response to imatinib alone, with further progression to ABP (see section 14 for definitions) 4. Performance status (ECOG/WHO) 5. Written informed consent Exclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients: 1. Age 2 (see Appendix 2) 3. Inability to provide written informed consent 4. Pregnancy 5. Chronic Phase disease 6. Formal refusal of any recommendation of a safe contraception 7. Alcohol or drug addiction 8. Altered hepatic or renal function as defined by AST/ALT or bilirubin > 3 times upper normal limits (UNL) 9. Serum creatinine > 265 umol/l or >3.0 mg/dl 10. 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.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Italy
Administrative Information
NCT ID † NCT00511069
Organization ID CML/033-26866138-CAN
Secondary IDs †† EUDRACT 2004-002977-22
Responsible Party
Study Sponsor † University of Bologna
Collaborators ††
Investigators † Principal Investigator: Giovanni Martinelli, MD, Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi di Bologna
Information Provided By
Verification Date November 2008
First Received Date † August 2, 2007
Last Updated Date November 21, 2008
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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