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

NCT00511069 | Completed Phase 2

• 2 other identifiers: CML/033-26866138-CANEUDRACT 2004-002977-22
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Bortezomib; CML033

Interventions

Bortezomib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Policlinico "S.Orsola-Malpighi"-Istituto di Ematologia "L e A Seragnoli"

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Leukemia

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Giovanni Martinelli, MD

  Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: July 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 24, 2008

Record last verified: 2008-11

Locations

IT (1)