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

Sponsor
University of Bologna (Other)
Overall Status
Completed
CT.gov ID
NCT00511069
Collaborator
(none)
3
Enrollment
1
Location
19.1
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
Study Start Date :
Jul 1, 2006
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Feb 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 <18

    2. Performance status (ECOG/WHO) > 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 <18

    2. Performance status (ECOG/WHO) > 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Policlinico "S.Orsola-Malpighi"-Istituto di Ematologia "L e A Seragnoli" Bologna Italy 40138

    Sponsors and Collaborators

    • University of Bologna

    Investigators

    • Principal Investigator: Giovanni Martinelli, MD, Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi di Bologna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00511069
    Other Study ID Numbers:
    • CML/033-26866138-CAN
    • EUDRACT 2004-002977-22
    First Posted:
    Aug 3, 2007
    Last Update Posted:
    Nov 24, 2008
    Last Verified:
    Nov 1, 2008
    Keywords provided by , ,
    Bortezomib
    CML033
    Additional relevant MeSH terms:
    Leukemia
    Bortezomib

    Study Results

    No Results Posted as of Nov 24, 2008