Myelodysplastic SyndromesPhase 1/2NCT00411905
Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
A Phase 1/2 study testing Bortezomib in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 15 sites in France.
Trial summary
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Bortezomib
- How many people
- 45 participants
- Where
- 15 sitesFrance
- Study dates
- 1 Jun 2006to 1 Aug 2011
- Phase
- Phase 1/2
- 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
- MDS with IPSS scores Int-2 or High
- Life expectancy greater than 6 months
- No other available treatment options
Who cannot join
- MDS with IPSS scores Low or Int-1
- > 30% bone marrow blasts
- clinical neuropathy of greater than grade 2
- ECOG Score 3 or 4
- Creatinine clearance of < 30 ml/min
- LMMC
Show all 9Show fewer
- Pregnant patients or lactating mothers
- Patients having received intensive chemotherapy in the 3 months prior to inclusion
- Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU Angers
Angers, 43033
Hopital Avicenne
Bobigny, 93009
Institut Bergonie
Bordeaux, 33076
CHU de Caen
Caen, 14033
CHU Dijon
Dijon, 21000
CHU Albert Michallon
Grenoble, 38043
CHU de Limoges
Limoges, 87046
Hopital Paoli Calmette
Marseille, 13273
CHU Archet
Nice, 06202
Hopital Cochin
Paris, 75014
Centre Hospitalier Joffre
Perpignan, 66046
Centre Henry Becquerel
Rouen, 76038
Centre Hospitalier Universitaire de STRASBOURG
Strasbourg, 67098
CHU Purpan
Toulouse, 31059
CHU Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.
Read the detailed description
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
- Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Cycles 2, 3, 4 :
- Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles
Responding patients may continue the treatment for 2 further cycles
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Bortezomib
- Keywords
- Myelodysplastic syndromes, IPSS Int-2 and High risk, Bortezomib, Low dose Cytarabine, Bone Marrow diseases
- Medical subject headings
- Myelodysplastic Syndromes, Bone Marrow Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Partial Response
Efficacy and safety evaluation
A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity.
The most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4
Measured: 18 mois
Secondary outcomes (1)
Hematological Improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study start1 Jun 2006
- Primary completion8 Jul 2010
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Essai ouvert multicentrique de phase I-II
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Francois DREYFUS, MD PhD, Principal investigator, Groupe francaise des Myelodysplasies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411905
- Sponsor's protocol ID
- GFM BAR-C-2005
- Status last verified
- Jul 2010
- First submitted
- 14 Dec 2006
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00411905
- Acronym / sponsor ID
- GFM BAR-C-2005
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Myelodysplastic syndromes, IPSS Int-2 and High risk, Bortezomib, Low dose Cytarabine, Bone Marrow diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Groupe Francophone des MyelodysplasiesUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 1 Jun 2006 (actual)
- Primary completion
- 8 Jul 2010 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 15 Dec 2006 (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.
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.
Detailed description
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
- Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Cycles 2, 3, 4 :
- Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles
Responding patients may continue the treatment for 2 further cycles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Essai ouvert multicentrique de phase I-II
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MDS with IPSS scores Int-2 or High
- Life expectancy greater than 6 months
- No other available treatment options
Key exclusion criteria (9 listed)
- MDS with IPSS scores Low or Int-1
- > 30% bone marrow blasts
- clinical neuropathy of greater than grade 2
- ECOG Score 3 or 4
- Creatinine clearance of < 30 ml/min
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
Complete Response
Partial Response
Efficacy and safety evaluation
Time frame: 18 mois
A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity. The most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4
1 secondary outcome
Hematological Improvement
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 7 Jan 2025.
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Myelodysplastic Syndromes
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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.
Francois DREYFUS, MD PhD principal investigator
Groupe francaise des Myelodysplasies
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bortezomib in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 15 sites in France.
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 3 inclusion and 9 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Complete Response. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 7 Jan 2025.