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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Bologna, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bortezomib

Drug

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Aug 3, 2007
Registry last updated: Nov 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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