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Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Primary Purpose

Chronic Myeloid Leukemia

Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Allogeneic tumor cell vaccine
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Outcomes

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.

Full Information

First Posted
September 11, 2005
Last Updated
April 27, 2011
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00162513
Brief Title
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
Official Title
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Withdrawn
Why Stopped
PI is no longer work at Hadassah
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Allogeneic tumor cell vaccine
Primary Outcome Measure Information:
Title
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
Secondary Outcome Measure Information:
Title
To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Slavin, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

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