NCT00162513

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
Last Updated

April 28, 2011

Status Verified

September 1, 2006

First QC Date

September 11, 2005

Last Update Submit

April 27, 2011

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.

Secondary Outcomes (1)

  • To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.

Interventions

Allogeneic tumor cell vaccineBIOLOGICAL

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients requiring immunosuppressive therapy or corticosteroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shimon Slavin, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 13, 2005

Study Start

December 1, 2006

Last Updated

April 28, 2011

Record last verified: 2006-09

Locations

IL(1)