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

Plain-language summary

This study evaluates the drug Bortezomib (Velcade) in patients with Philadelphia chromosome positive (Ph+) leukemia. Ph-positive patients aged 18 and older with chronic-phase or advanced-phase leukemia who did not respond adequately to imatinib or who lost their response could take part. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

University of Bologna

Intervention

Bortezomib

Start date

7/1/2006

Estimated completion

2/1/2008

Countries

Italy

Related genes

Locations

• Bologna, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.