MyelofibrosisPhase 2NCT00287261
A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
A Phase 2 study testing zoledronic acid in people with Myelofibrosis and Myeloid Metaplasia, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in 6 countries.
Trial summary
In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Myeloid Metaplasia
- What is being tested?
- zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Feb 2006to Mar 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
- male or female and at least 18 years-of-age histologically confirmed diagnosis of myelofibrosis with myeloid metaplasia (MMM). This includes patients with agnogenic myeloid metaplasia (also known as idiopathic myelofibrosis) and patients with a preceding history of polycythemia vera or essential thrombocytemia (also known as post-polycytemic myelofibrosis). (see Appendix A) patients with low, intermediate and high risk disease categories (following the Dupriez score) may be included presence of measurable, clinically relevant disease manifestations (especially for low risk patients) ECOG performance status of 0, 1 or 2 life expectancy of at least 3 months Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomization written informed consent
Who cannot join
- diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7 disease or acute panmyelosis with myelofibrosis) presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement as detected by RT-PCR in bone marrow or peripheral blood any anti-myelofibrosis drug therapy during the last 4 weeks. This includes chemotherapy, androgens, steroids, thalidomide, hematopoietic growth factors or any other investigational drug patients that have received bisphosphonates in the previous 3 months known allergy or intolerance to bisphosphonates abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/min (creatinine clearance (CrCl) is calculated using the Cockcroft and Gault formula) (see Appendix F) corrected serum calcium < 8.0 mg/dL . Corrected serum calcium (mg/dl) = measured calcium (mg/dl) + 0.8[4 - patient serum albumin (g/dl)] patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including: uncontrolled infections uncontrolled type 2 Diabetes Mellitus diseases with influence on bone metabolism such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up current active dental problems including infection of the teeth or jawbone (maxilla or mandibula); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) patients with a history of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative patients treated with any systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days pregnant or breast feeding females
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).
Read the detailed description
This is a prospective, multicentre phase II study in adult patients with documented MMM and requiring therapy for their disease. Patients will be treated every 3 weeks with 4 mg zoledronic acid (Zometa), administered by a 15 min. intravenous infusion. Study duration is 36 weeks (12 infusions). After the study it is recommended to continue treatment until disease progression, or the occurrence of unacceptable treatment-related toxicity.
Objectives of the trial are:
Primary objectives: the effect of monthly infusion of zoledronic acid 4 mg on:
hemoglobin level, spleen size
Secondary objectives the effect of monthly infusion of zoledronic acid 4 mg on: red blood cell transfusion need performance status constitutional symptoms leukocyte count thrombocyte count bone marrow fibrosis serum LDH
- Conditions
- Myelofibrosis, Myeloid Metaplasia
- Being tested
- zoledronic acid
- Keywords
- myelofibrosis, D009191
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
4 mg IV every 3 weeks for 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| zometa | Experimental | 3-weekly infusion of zometa (zoledronic acid) 4 mg Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of monthly zoledronic acid infusion on hemoglobin level and spleen size
Measured: 36 weeks
Secondary outcomes (8)
red blood cell transfusion need
Measured: 36 weeks
performance status
Measured: 36 weeks
constitutional symptoms
Measured: 36 weeks
leukocyte count
Measured: 36 weeks
thrombocyte count
Measured: 36 weeks
serum LDH
Measured: 36 weeks
bone marrow histology
Measured: 36 weeks
safety of zometa infusions
Measured: until progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Hans Wildiers, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Michel Delforge, MD, PhD, Principal investigator, University Hospital Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287261
- Sponsor's protocol ID
- CZOL446G2422
- Status last verified
- Dec 2014
- First submitted
- 2 Feb 2006
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
- ClinicalTrials.gov ID
- NCT00287261
- Acronym / sponsor ID
- CZOL446G2422
- Conditions
- Myelofibrosis, Myeloid Metaplasia
- Keywords
- myelofibrosis, D009191
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Feb 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.
In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).
Detailed description
This is a prospective, multicentre phase II study in adult patients with documented MMM and requiring therapy for their disease. Patients will be treated every 3 weeks with 4 mg zoledronic acid (Zometa), administered by a 15 min. intravenous infusion. Study duration is 36 weeks (12 infusions). After the study it is recommended to continue treatment until disease progression, or the occurrence of unacceptable treatment-related toxicity.
Objectives of the trial are:
Primary objectives: the effect of monthly infusion of zoledronic acid 4 mg on:
hemoglobin level, spleen size
Secondary objectives the effect of monthly infusion of zoledronic acid 4 mg on: red blood cell transfusion need performance status constitutional symptoms leukocyte count thrombocyte count bone marrow fibrosis serum LDH
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zometa | Experimental | Drug: zoledronic acid3-weekly infusion of zometa (zoledronic acid) 4 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female and at least 18 years-of-age histologically confirmed diagnosis of myelofibrosis with myeloid metaplasia (MMM). This includes patients with agnogenic myeloid metaplasia (also known as idiopathic myelofibrosis) and patients with a preceding history of polycythemia vera or essential thrombocytemia (also known as post-polycytemic myelofibrosis). (see Appendix A) patients with low, intermediate and high risk disease categories (following the Dupriez score) may be included presence of measurable, clinically relevant disease manifestations (especially for low risk patients) ECOG performance status of 0, 1 or 2 life expectancy of at least 3 months Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomization written informed consent
Key exclusion criteria (1 listed)
- diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7 disease or acute panmyelosis with myelofibrosis) presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement as detected by RT-PCR in bone marrow or peripheral blood any anti-myelofibrosis drug therapy during the last 4 weeks. This includes chemotherapy, androgens, steroids, thalidomide, hematopoietic growth factors or any other investigational drug patients that have received bisphosphonates in the previous 3 months known allergy or intolerance to bisphosphonates abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/min (creatinine clearance (CrCl) is calculated using the Cockcroft and Gault formula) (see Appendix F) corrected serum calcium < 8.0 mg/dL . Corrected serum calcium (mg/dl) = measured calcium (mg/dl) + 0.8[4 - patient serum albumin (g/dl)] patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including: uncontrolled infections uncontrolled type 2 Diabetes Mellitus diseases with influence on bone metabolism such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up current active dental problems including infection of the teeth or jawbone (maxilla or mandibula); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) patients with a history of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative patients treated with any systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days pregnant or breast feeding females
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 |
|---|---|---|
| zoledronic acid4 mg IV every 3 weeks for 36 weeks | Drug | zometa |
Primary outcome
effect of monthly zoledronic acid infusion on hemoglobin level and spleen size
Time frame: 36 weeks
8 secondary outcomes
red blood cell transfusion need
Time frame: 36 weeks
performance status
Time frame: 36 weeks
constitutional symptoms
Time frame: 36 weeks
leukocyte count
Time frame: 36 weeks
thrombocyte count
Time frame: 36 weeks
serum LDH
Time frame: 36 weeks
bone marrow histology
Time frame: 36 weeks
safety of zometa infusions
Time frame: until progression or death
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 9 Dec 2014.
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A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
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Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
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Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
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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.
Michel Delforge, MD, PhD principal investigator
University Hospital Leuven, Belgium
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zoledronic acid in people with Myelofibrosis and Myeloid Metaplasia, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in 6 countries.
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 1 inclusion and 1 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Belgium, France, Germany, Israel and 1 more country. 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.
What does the primary outcome measure?
effect of monthly zoledronic acid infusion on hemoglobin level and spleen size (time frame: 36 weeks). 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 9 Dec 2014.