Allogeneic Tumor Cell Vaccination in Patients With Chroni... | NCT00162513

Studies
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

NCT00162513

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Apr 28, 2011Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Chronic Myeloid Leukemia

Interventions

Allogeneic tumor cell vaccine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI is no longer work at Hadassah

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2011

Last Update Posted Date

Apr 28, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Allogeneic tumor cell vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.

Secondary Outcomes

Measure	Description	Time Frame
To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shimon Slavin, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided