Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

NCT ID: NCT00162513

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches.

Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated.

The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.

Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Allogeneic tumor cell vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients above the age of 55 consenting to participate in the study.
* Patients with documented CML with Philadelphia chromosome t (9:21)
* Patients with no HLA matched sibling.
* Patients eligible for BMT for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed BMT.
* Patients with contra-indication to BMT.
* Patients refusing BMT.
* Patients who failed interferon alpha, ARAc and/or Glivec.

Exclusion Criteria

* Patients requiring immunosuppressive therapy or corticosteroids.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Shimon Slavin, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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191199-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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