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


N/A
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome, Acute Myeloid Leukemia

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Vincent Ho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

08-159

NCT ID:

NCT00809367

Start Date:

October 2008

Completion Date:

May 2011

Related Keywords:

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • MDS
  • AML
  • banking study
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115