Collection and Banking of Leukemia Cells MDS/AML

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Vincent T. Ho, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00809367
First received: December 15, 2008
Last updated: February 6, 2013
Last verified: January 2013
  Purpose

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 Intervention
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Other: Collection of Leukemia Cells

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned 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
Other: Collection of Leukemia Cells
Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809367

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Vincent Ho, MD Dana-Farber Cancer Institute
  More Information

No publications provided

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
Study First Received: December 15, 2008
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
MDS
AML
banking study

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

ClinicalTrials.gov processed this record on April 23, 2014