Clincosm LogoSign in Get a demo

Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00149032
Collaborator
(none)
50
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Allogeneic stem cell transplantation is the only effective treatment to patients resistant to conventional chemotherapy. Donor lymphocytes infusion (DLI) serve as a routine treatment of choice for patients relapsing following allogeneic stem cell transplantation. The present proposal is presented for introducing the use of immune rather than naive donor lymphocytes for patients with resistant relapse and resistant to DLI. DLI primed in-vitro against tumor cells of host origin or against host alloantigens presented by parental alloantigens in one way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and graft-vs-tumor effects, while down-regulating graft-vs-host disease (GVHD).

Condition or Disease Intervention/Treatment Phase
  • Procedure: DLI sensitized against antigens expressed by the host.
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Study Start Date :
Aug 1, 2001

Outcome Measures

Primary Outcome Measures

  1. Introducing more effective graft vs leukemia and graft vs tumor effects with immune donor lymphocytes in patients relapsing following allogeneic bone marrow or blood stem cell transplantation []

Secondary Outcome Measures

  1. Upregulating of anti-tumor effects while minimizing anti-host responses []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients with hematologic malignancy or metastatic solid tumor relapsing following allogeneic bone marrow or blood stem cell transplantation (alloBMT) or non-myeloablative stem cell transplantation resistant to DLI with no GVHD when taken off anti-GVHD prophylaxis.

  • Patients with documented chimerism to confirm induction of host-vs-graft transplantation tolerance.

Exclusion Criteria:

  • Patients not consenting to participate in the study, or minors without approved parental consent.

  • Patients with other diseases or complications that may limit their life span other than their basic disease.

  • Pregnant or lactating women.

  • Non-compliant patients or patients with poor performance status with life expectancy, e.g. 6 weeks.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hadassah Medical Organization Jerusalem Israel 91120

Sponsors and Collaborators

  • Hadassah Medical Organization

Investigators

  • Principal Investigator: Shimon Slavin, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00149032
Other Study ID Numbers:
  • 240801-HMO-CTIL
First Posted:
Sep 8, 2005
Last Update Posted:
Apr 8, 2011
Last Verified:
Sep 1, 2005
Keywords provided by , ,
Metastatic solid tumor
Additional relevant MeSH terms:
Neoplasm Metastasis
Hematologic Neoplasms

Study Results

No Results Posted as of Apr 8, 2011