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This study has been withdrawn prior to enrollment.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:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162513
First received: September 11, 2005
Last updated: April 27, 2011
Last verified: September 2006
  Purpose

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 Intervention Phase
Chronic Myeloid Leukemia
Biological: Allogeneic tumor cell vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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

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

Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162513

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162513     History of Changes
Other Study ID Numbers: 191199-HMO-CTIL
Study First Received: September 11, 2005
Last Updated: April 27, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014