Collection and Banking of Leukemia Cells for Vaccine Generation in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

This study is currently recruiting participants.

Verified by Dana-Farber Cancer Institute, March 2009

First Received: December 15, 2008 Last Updated: March 13, 2009 History of Changes

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital National Institutes of Health (NIH)
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00809367

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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	96
Study Start Date:	October 2008
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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 to 70 Years
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 18-70
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

Contacts

Contact: Vincent Ho, MD

617-632-5938

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Vincent Ho, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Vincent T. Ho, MD )
Study ID Numbers:	08-159
Study First Received:	December 15, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00809367 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

MDS
AML
banking study

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplastic Syndromes
Leukemia, Myeloid
Bone Marrow Diseases
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009