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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00149032
First received: September 7, 2005
Last updated: April 7, 2011
Last verified: September 2005
History of Changes
  Purpose

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 Intervention Phase
Hematological Malignancy
Neoplasm Metastasis
 Procedure: DLI sensitized against antigens expressed by the host.
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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:
  • Upregulating of anti-tumor effects while minimizing anti-host responses

Estimated Enrollment: 50
Study Start Date: August 2001
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149032

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: NCT00149032     History of Changes
Other Study ID Numbers: 240801-HMO-CTIL
Study First Received: September 7, 2005
Last Updated: April 7, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Metastatic solid tumor

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Hematologic Neoplasms
Neoplastic Processes
 Pathologic Processes
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013