Collection and Banking of Leukemia Cells MDS/AML

Not Applicable

Completed

• Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia
• Interventions: Other: Collection of Leukemia Cells

• Registration Number: NCT00809367
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collection of Leukemia Cells	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States