Collection and Banking of Leukemia Cells MDS/AML

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809367
• Other study ID #: 08-159
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: February 6, 2013
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: January 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No