Collection and Banking of Leukemia Cells MDS/AML

Dana-Farber Cancer Institute

Status: Completed

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Other: Collection of Leukemia Cells

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00809367

08-159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

90 participants in 1 patient group

Collection of Leukemia Cells

Other group

Description:

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

Treatment:

Other: Collection of Leukemia Cells