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NCT Number: NCT00809367

Collection and Banking of Leukemia Cells MDS/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.

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Key information

Conditions

Myelodysplastic Syndrome Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of Leukemia Cells

Other

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

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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2008
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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