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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511069
First Posted: August 3, 2007
Last Update Posted: November 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bologna
  Purpose

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 Intervention Phase
Leukemia Drug: Bortezomib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Enrollment: 3
Study Start Date: July 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511069


Locations
Italy
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
  More Information

Responsible Party: Giovanni Martinelli, Dipartimento di Ematologia "seragnoli"- Policlinico Sant'Orsola Bologna
ClinicalTrials.gov Identifier: NCT00511069     History of Changes
Other Study ID Numbers: CML/033-26866138-CAN
EUDRACT 2004-002977-22
First Submitted: August 2, 2007
First Posted: August 3, 2007
Last Update Posted: November 24, 2008
Last Verified: November 2008

Keywords provided by University of Bologna:
Bortezomib
CML033

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Bortezomib
Antineoplastic Agents