Collection and Banking of Leukemia Cells MDS/AML
1 other identifier
interventional
90
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFebruary 7, 2013
January 1, 2013
2.6 years
December 15, 2008
February 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Study Arms (1)
Collection of Leukemia Cells
OTHEROther: Collection of Leukemia Cells Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis
Interventions
Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Ho, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 17, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
February 7, 2013
Record last verified: 2013-01