LeukemiaPhase 1NCT00505700
VELCADE in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia
A Phase 1 study testing velcade, Idarubicin and Cytarabine in people with Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- velcade, Idarubicin and Cytarabine
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2003to Sep 2005
- Phase
- Phase 1
- 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
- Patients must be 18 years or older.
- Unequivocal histologic diagnosis of AML (>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic leukemia).
- For patients less than 60, disease must have previously achieved CR and then relapsed (>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic leukemia).). These patients must have a period of remission of >3 months (beginning with the time when the ANC >1,500/ul, platelets >100,000/ul and < 5% marrow blasts are present).
- Patients 60 years of age or older may have relapsed disease or may have previously untreated AML (>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic leukemia).
- Patients may have prior myelodysplasia. Patients may have prior treatment for myelodysplasia.
- Patients may have had prior chemotherapy for another malignancy or an antecedent hematologic disorder such as myelodysplasia.
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- Patients must have an ECOG performance status 0-3.
- Patients must have all of the following pretreatment laboratory values within 21 days of enrollment: total bilirubin <= 1.5 X the upper limit of normal (ULN), ALT and AST <= 2.5 X the ULN, creatinine <= 2.0 mg/dl.
- Male patients need to use an appropriate method of barrier contraception during the study.
- Female patients must be post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e. a hormonal contraceptive, an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Patients must give voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Who cannot join
- If less than 60 years old, patient has received chemotherapy within the last three months (90 days).
- Patients with untreated AML < 60 years old.
- Other active malignancy (with the exception of basal and squamous cell skin cancer) at the time of study entry.
- Patient has hypersensitivity to boron or mannitol
- Severe pulmonary or cardiac disease.
- History of congestive heart failure or ejection fraction < 40%.
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- Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patients with M3 AML (acute promyelocytic leukemia) by FAB or WHO as described in 9.3.
- Patients with HIV infection.
- Patients with known active hepatitis B or C.
- Patients with known central nervous system leukemia. A lumbar puncture is not required unless CNS involvement is clinically suspected.
- Patients who are pregnant or breast feeding.
- Patients with major surgery within the 4 weeks prior to trial enrollment.
- Patients with ³ Grade 2 peripheral neuropathy within 21 days before enrollment.
- Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. If the condition becomes controlled, the patient may become eligible.
- Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel/ Deaconess Medical Center
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase I Dose Escalating Trial of VELCADE (PS-341) in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia
The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and idarubicin. Various molecular markers associated with response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray analyses. The study endpoints are maximum tolerated dose and response to treatment.
- Conditions
- Leukemia
- Being tested
- velcade, Idarubicin, Cytarabine
- Keywords
- acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
velcadeDrug
IdarubicinDrug
CytarabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJul 2003
- Primary completionSep 2005
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.
- More trials run by Massachusetts General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Investigators
- Philip C Amrein, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505700
- Sponsor's protocol ID
- 03-103
- Status last verified
- Sep 2010
- First submitted
- 19 Jul 2007
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalating Trial of VELCADE (PS-341) in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00505700
- Acronym / sponsor ID
- 03-103
- Conditions
- Leukemia
- Keywords
- acute myeloid leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jul 2003
- Primary completion
- Sep 2005 (actual)
- First posted
- 23 Jul 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.
The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and idarubicin. Various molecular markers associated with response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray analyses. The study endpoints are maximum tolerated dose and response to treatment.
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 (11 listed)
- Patients must be 18 years or older.
- Unequivocal histologic diagnosis of AML (>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic leukemia).
- For patients less than 60, disease must have previously achieved CR and then relapsed (>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic leukemia).). These patients must have a period of remission of >3 months (beginning with the time when the ANC >1,500/ul, platelets >100,000/ul and < 5% marrow blasts are present).
- Patients 60 years of age or older may have relapsed disease or may have previously untreated AML (>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic leukemia).
- Patients may have prior myelodysplasia. Patients may have prior treatment for myelodysplasia.
Key exclusion criteria (16 listed)
- If less than 60 years old, patient has received chemotherapy within the last three months (90 days).
- Patients with untreated AML < 60 years old.
- Other active malignancy (with the exception of basal and squamous cell skin cancer) at the time of study entry.
- Patient has hypersensitivity to boron or mannitol
- Severe pulmonary or cardiac disease.
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 |
|---|---|---|
| velcade | Drug | – |
| Idarubicin | Drug | – |
| Cytarabine | 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 Sep 2010.
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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.
Philip C Amrein, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing velcade, Idarubicin and Cytarabine in people with Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
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 11 inclusion and 16 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 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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.
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 Sep 2010; AzTrials last refreshed its copy on 8 Nov 2026.