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Collection and Banking of Leukemia Cells MDS/AML

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ClinicalTrials.gov Identifier: NCT00809367
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome Acute Myeloid Leukemia Other: Collection of Leukemia Cells

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  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML
Study Start Date : October 2008
Primary Completion Date : May 2011
Study Completion Date : May 2011

Arms and Interventions

Arm Intervention/treatment
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
Other: Collection of Leukemia Cells
Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809367

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
National Institutes of Health (NIH)
Principal Investigator: Vincent Ho, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Vincent T. Ho, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00809367     History of Changes
Other Study ID Numbers: 08-159
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: January 2013

Keywords provided by Vincent T. Ho, MD, Dana-Farber Cancer Institute:
banking study

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions