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Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

This study has been withdrawn prior to enrollment.
(PI is no longer work at Hadassah)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162513
First Posted: September 13, 2005
Last Update Posted: April 28, 2011
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.
Information provided by:
Hadassah Medical Organization
September 11, 2005
September 13, 2005
April 28, 2011
December 2006
Not Provided
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
Same as current
Complete list of historical versions of study NCT00162513 on ClinicalTrials.gov Archive Site
To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.
Same as current
Not Provided
Not Provided
 
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myeloid Leukemia
Biological: Allogeneic tumor cell vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
Not Provided
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00162513
191199-HMO-CTIL
Not Provided
Not Provided
Not Provided
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Hadassah Medical Organization
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP