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Collection and Banking of Leukemia Cells MDS/AML

Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00809367
Enrollment
90
Registered
2008-12-17
Start date
2008-10-31
Completion date
2011-05-31
Last updated
2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Keywords

MDS, AML, banking study

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.

Interventions

OTHERCollection of Leukemia Cells

Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026