18 Yaş Üstü Ph+ Lösemi Hastalarının Tedavisinde Velcade (Bortezomib - PS341)

Sade dilde özet

Bu çalışma, Philadelphia kromozomu pozitif (Ph+) lösemi hastalarında Bortezomib (Velcade) ilacını değerlendirmektedir. Çalışmaya, imatinib tedavisine yeterli yanıt vermeyen veya yanıtını kaybetmiş, 18 yaş ve üzeri Ph pozitif kronik faz ya da ileri faz lösemi hastaları katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

University of Bologna

Müdahale

Bortezomib

Başlangıç

01.07.2006

Tahmini bitiş

01.02.2008

Ülkeler

Italy

İlgili genler

Merkezler

• Bologna, Italy

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.