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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This study has been withdrawn prior to enrollment.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

September 7, 2005
April 7, 2011
August 2001
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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
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.
Complete list of historical versions of study NCT00149032 on ClinicalTrials.gov Archive Site
Upregulating of anti-tumor effects while minimizing anti-host responses
Upregulating of anti-tumor effects while minimizing anti-host responses.
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Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

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).
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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematological Malignancy
  • Neoplasm Metastasis
Procedure: DLI sensitized against antigens expressed by the host.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00149032
240801-HMO-CTIL
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Hadassah Medical Organization
Not Provided
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Hadassah Medical Organization
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP