LeukemiaPhase 2NCT00511069
Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
A Phase 2 study testing Bortezomib in people with Leukemia, run by University of Bologna at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Bortezomib
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2006to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico "S.Orsola-Malpighi"-Istituto di Ematologia "L e A Seragnoli"
Bologna, 40138
About this study
Official title: A Phase II Study of 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.
- Conditions
- Leukemia
- Being tested
- Bortezomib
- Keywords
- Bortezomib, CML033
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startJul 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Martinelli, MD, Principal investigator, Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511069
- Sponsor's protocol ID
- CML/033-26866138-CAN
- Other IDs
- EUDRACT 2004-002977-22
- Status last verified
- Nov 2008
- First submitted
- 2 Aug 2007
- Last updated
- 24 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia
- ClinicalTrials.gov ID
- NCT00511069
- Acronym / sponsor ID
- CML/033-26866138-CAN
- Conditions
- Leukemia
- Keywords
- Bortezomib, CML033
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (27 listed)
- Age <18
- Performance status (ECOG/WHO) > 2 (see Appendix 2)
- Inability to provide written informed consent
- Pregnancy
- Accelerated or blastic phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Martinelli, MD principal investigator
Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib in people with Leukemia, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2008.