Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Chronic Myeloid Leukemia Clinical Trial

Official title:

Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00162513
• Other study ID #: 191199-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 11, 2005
• Last updated: April 27, 2011
• Start date: December 2006

Study information

• Verified date: September 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Biological:
• Allogeneic tumor cell vaccine

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
Secondary	To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.