Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
This study has been withdrawn prior to enrollment.
Information provided by:
Hadassah Medical Organization
First received: September 7, 2005
Last updated: April 7, 2011
Last verified: September 2005
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).
Procedure: DLI sensitized against antigens expressed by the host.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
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:
| Study Start Date:
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149032
|Hadassah Medical Organization
|Jerusalem, Israel, 91120 |
Hadassah Medical Organization
||Shimon Slavin, MD
||Hadassah Medical Organization
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2005
||April 7, 2011
||Israel: Israeli Health Ministry Pharmaceutical Administration
Keywords provided by Hadassah Medical Organization:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
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