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Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162513
Recruitment Status : Withdrawn (PI is no longer work at Hadassah)
First Posted : September 13, 2005
Last Update Posted : April 28, 2011
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Biological: Allogeneic tumor cell vaccine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
Study Start Date : December 2006

Primary Outcome Measures :
  1. Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.

Secondary Outcome Measures :
  1. To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162513

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Layout table for additonal information Identifier: NCT00162513    
Other Study ID Numbers: 191199-HMO-CTIL
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: September 2006
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases