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

Primary Purpose

Leukemia

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Bortezomib

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Bortezomib, CML033

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00511069

First Posted

August 2, 2007

Last Updated

November 21, 2008

Sponsor

University of Bologna

1. Study Identification

Unique Protocol Identification Number

NCT00511069

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Bologna

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

Bortezomib, CML033

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Bortezomib

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni Martinelli, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bologna

ZIP/Postal Code

40138

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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