Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Collection of Leukemia Cells
Other: Collection of Leukemia Cells Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis
Intervention: Collection of Leukemia Cells (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Vincent T. Ho, MD
Principal Investigator
Dana-Farber Cancer Institute