Myelodysplastic SyndromeNCT00809367
Collection and Banking of Leukemia Cells MDS/AML
A study testing Collection of Leukemia Cells in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The goal of this research study is to determine if it is feasible to collect leukemia cells from patients ahead of time (before they undergo further treatments) so that these cells (after being radiated so they will no longer grow or divide) can be given back to them as a cancer vaccine if/after the participant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- What is being tested?
- Collection of Leukemia Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2011
- Phase
- Interventional
- 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 with AML will be eligible for banking at the time of relapse or primary induction failure or at the time of AML diagnosis they are 60 years of age or older, AML arising out of background MDS or MPD or AML known with high risk cytogenetics
- Patients with MDS-RAEB-1 or RAEB-II, CMML-1 or CMML-II
- Patients must have >5% blast in bone marrow or peripheral blood
- ECOG Performance Status 0-2
- Age greater than or equal to 18 years
- Reasonable likelihood, in the physician's opinion, that the patient will be a candidate for allogeneic stem cell transplant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML
The goal of this research study is to determine if it is feasible to collect leukemia cells from patients ahead of time (before they undergo further treatments) so that these cells (after being radiated so they will no longer grow or divide) can be given back to them as a cancer vaccine if/after the participant receives a bone marrow or blood stem cell transplant in the future. The purpose of the research study will be to collect, freeze and store leukemia calls from participants blood or bone marrow. This study is a companion study to a vaccine study.
Read the detailed description
- Leukemia cells will be collected by one or more of the following methods: 1)Routine blood draw 2)Bone marrow aspirate 3) Leukapheresis. The physician and study staff will determine which of the methods above is best suited for each participant.
- After collection, the leukemia cells will be transported to the Cell Manipulation Core Facility (CMCF) at the Dana-Farber Cancer Institute, where they will be frozen until the time of vaccine administration.
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Being tested
- Collection of Leukemia Cells
- Keywords
- MDS, AML, banking study
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Leukemia CellsOther
Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis
| Study group | Role | What they receive |
|---|---|---|
| Collection of Leukemia Cells | Other | Other: Collection of Leukemia Cells Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis Receives: Other: Collection of Leukemia Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of banking leukemic blood or marrow samples from patients with advanced MDS or AML such that these cells could be used for tumor cell vaccination at a later date.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Vincent T. Ho, MD, Dana-Farber Cancer Institute
- Investigators
- Vincent Ho, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809367
- Sponsor's protocol ID
- 08-159
- Status last verified
- Jan 2013
- First submitted
- 15 Dec 2008
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML
- ClinicalTrials.gov ID
- NCT00809367
- Acronym / sponsor ID
- 08-159
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Keywords
- MDS, AML, banking study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institutes of Health (NIH)
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Dec 2008 (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 goal of this research study is to determine if it is feasible to collect leukemia cells from patients ahead of time (before they undergo further treatments) so that these cells (after being radiated so they will no longer grow or divide) can be given back to them as a cancer vaccine if/after the participant receives a bone marrow or blood stem cell transplant in the future. The purpose of the research study will be to collect, freeze and store leukemia calls from participants blood or bone marrow. This study is a companion study to a vaccine study.
Detailed description
- Leukemia cells will be collected by one or more of the following methods: 1)Routine blood draw 2)Bone marrow aspirate 3) Leukapheresis. The physician and study staff will determine which of the methods above is best suited for each participant.
- After collection, the leukemia cells will be transported to the Cell Manipulation Core Facility (CMCF) at the Dana-Farber Cancer Institute, where they will be frozen until the time of vaccine administration.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of Leukemia Cells | Other | Other: Collection of Leukemia CellsOther: Collection of Leukemia Cells Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with AML will be eligible for banking at the time of relapse or primary induction failure or at the time of AML diagnosis they are 60 years of age or older, AML arising out of background MDS or MPD or AML known with high risk cytogenetics
- Patients with MDS-RAEB-1 or RAEB-II, CMML-1 or CMML-II
- Patients must have >5% blast in bone marrow or peripheral blood
- ECOG Performance Status 0-2
- Age greater than or equal to 18 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Collection of Leukemia CellsCollection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis | Other | Collection of Leukemia Cells |
Primary outcome
To determine the feasibility of banking leukemic blood or marrow samples from patients with advanced MDS or AML such that these cells could be used for tumor cell vaccination at a later date.
Time frame: 2 years
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 Feb 2013.
Related trials for Myelodysplastic Syndrome
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Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
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Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Vincent Ho, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of Leukemia Cells in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by Dana-Farber Cancer Institute 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 6 inclusion and 0 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 Feb 2013. 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.
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?
To determine the feasibility of banking leukemic blood or marrow samples from patients with advanced MDS or AML such that these cells could be used for tumor cell vaccination at a later date. (time frame: 2 years). 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 Feb 2013.