LeukemiaPhase 2NCT01891968
Bortezomib for Low or Intermediate-1 Myelodysplastic Syndrome (MDS) With p65 Activation
A Phase 2 study testing Bortezomib in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if bortezomib can help to control MDS. The safety of this drug will also be studied. Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2013to 18 Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, indicating that that the patient is aware of the investigational nature of the study in keeping with the policies of MD Anderson Cancer Center (MDACC) and with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Presence of phosphorylated p65 NF-kB component in at least 5% of bone marrow cells
- Age >/= 18 years of age at time of signing consent
- Confirmed MDS by bone marrow biopsy according to World Health Organization (WHO) or French-American-British (FAB) criteria.
- Classification by the International Prognostic Score System (IPSS) as low or intermediate-1 risk MDS according to cytogenetics, blood cytopenias and % bone marrow blasts within 28 days of the first dose of treatment in this study.
- Patients must have received at least one prior therapy for MDS. Patients could have received transplant for MDS
Show all 12Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Adequate liver function: Total bilirubin </= 1.5 × the upper limit of normal (ULN), unless presence of Gilbert's Syndrome. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 × ULN or </= 5.0 ULN if hepatic involvement is present as determined by the investigator
- Adequate renal function: Serum creatinine </= 2 mg/dL or a calculated creatinine clearance of >/= 50 mL/min (using the Cockcroft and Gault method).
- Male patients, even if surgically sterilized (ie, status postvasectomy), who agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment, or agree to completely abstain from heterosexual intercourse.
- Female patients who are postmenopausal for at least 1 year before the Screening visit, or are surgically sterile, or if they are of childbearing potential, must have a negative pregnancy test within 72 hours of treatment start date and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- Significant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
- Any severe concurrent disease or condition (including active, uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia) that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Pregnant or lactating females.
- Patient has >/= Grade 2 peripheral neuropathy
- Patient had myocardial infarction within 6 months prior to 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. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to bortezomib, boron, or mannitol
Show all 9Show fewer
- Current diagnosis of another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Treatment with other investigational agents, chemotherapy, or immunotherapy within 14 days of the start of this trial and throughout the duration of this trial.
- Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Subcutaneous Bortezomib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
The goal of this clinical research study is to learn if bortezomib can help to control MDS. The safety of this drug will also be studied.
Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive bortezomib as an injection under the skin on Days 1, 4, 8, and 11 of each 21-day cycle.
Study Visits:
At each visit, you will be asked about any drugs you may be taking and any side effects you may be having.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine tests.
On Day 21 of Cycles 1 and 3, you will have a bone marrow aspiration and/or biopsy to check the status of the disease and for cytogenetic testing.
On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be drawn for routine tests.
If your doctor thinks it is needed, you may have additional bone aspirations and/or biopsies to check the status of the disease and/or for cytogenetic testing.
Length of Treatment:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you are able to have an allogeneic stem cell transplant (a stem cell transplant from a donor), or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of- treatment visit.
End-of-Treatment Visit:
At 30 days after your last dose of study drug:
- You will be asked about any drugs you may be taking and any side effects you may have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If your doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for cytogenetic testing.
This is an investigational study. Bortezomib is FDA approved and commercially available to treat multiple myeloma and mantle cell lymphoma. Giving it to patients with MDS is investigational.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Bortezomib
- Keywords
- Leukemia, Myelodysplastic syndrome, MDS, Low or intermediate-1, Bortezomib, Velcade, LDP-341, MLN341, PS-341
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade, LDP-341, MLN341, PS-341
1.3 mg/m2 subcutaneously on days 1, 4, 8 and 11 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (OR)
Primary outcome is overall response (OR) including hematologic improvement defined by International Working Group (IWG), complete remission, partial remission and marrow complete remission.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study start7 Aug 2013
- Primary completion18 Jan 2017
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Guillermo Garcia-Manero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891968
- Sponsor's protocol ID
- 2012-0562
- Other IDs
- NCI-2013-01730
- Status last verified
- Mar 2018
- First submitted
- 28 Jun 2013
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Subcutaneous Bortezomib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01891968
- Acronym / sponsor ID
- 2012-0562
- Conditions
- Leukemia
- Keywords
- Leukemia, Myelodysplastic syndrome, MDS, Low or intermediate-1, Bortezomib, Velcade, LDP-341, MLN341
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 7 Aug 2013 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if bortezomib can help to control MDS. The safety of this drug will also be studied.
Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive bortezomib as an injection under the skin on Days 1, 4, 8, and 11 of each 21-day cycle.
Study Visits:
At each visit, you will be asked about any drugs you may be taking and any side effects you may be having.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine tests.
On Day 21 of Cycles 1 and 3, you will have a bone marrow aspiration and/or biopsy to check the status of the disease and for cytogenetic testing.
On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be drawn for routine tests.
If your doctor thinks it is needed, you may have additional bone aspirations and/or biopsies to check the status of the disease and/or for cytogenetic testing.
Length of Treatment:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you are able to have an allogeneic stem cell transplant (a stem cell transplant from a donor), or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of- treatment visit.
End-of-Treatment Visit:
At 30 days after your last dose of study drug:
- You will be asked about any drugs you may be taking and any side effects you may have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If your doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for cytogenetic testing.
This is an investigational study. Bortezomib is FDA approved and commercially available to treat multiple myeloma and mantle cell lymphoma. Giving it to patients with MDS is investigational.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: BortezomibBortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, indicating that that the patient is aware of the investigational nature of the study in keeping with the policies of MD Anderson Cancer Center (MDACC) and with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Presence of phosphorylated p65 NF-kB component in at least 5% of bone marrow cells
- Age >/= 18 years of age at time of signing consent
- Confirmed MDS by bone marrow biopsy according to World Health Organization (WHO) or French-American-British (FAB) criteria.
- Classification by the International Prognostic Score System (IPSS) as low or intermediate-1 risk MDS according to cytogenetics, blood cytopenias and % bone marrow blasts within 28 days of the first dose of treatment in this study.
Key exclusion criteria (9 listed)
- Significant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
- Any severe concurrent disease or condition (including active, uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia) that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Pregnant or lactating females.
- Patient has >/= Grade 2 peripheral neuropathy
- Patient had myocardial infarction within 6 months prior to 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. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
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 |
|---|---|---|
| BortezomibAlso: Velcade, LDP-341, MLN341, PS-3411.3 mg/m2 subcutaneously on days 1, 4, 8 and 11 of a 21 day cycle. | Drug | Bortezomib |
Primary outcome
Overall Response (OR)
Time frame: 8 weeks
Primary outcome is overall response (OR) including hematologic improvement defined by International Working Group (IWG), complete remission, partial remission and marrow complete remission.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Guillermo Garcia-Manero, MD principal investigator
M.D. Anderson Cancer Center
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 M.D. Anderson Cancer Center at 1 site 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 12 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 23 Apr 2018. 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 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 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?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response (OR) (time frame: 8 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 23 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.