Back to resultsTreatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Primary Purpose
Hematological Malignancy, Neoplasm Metastasis
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
DLI sensitized against antigens expressed by the host.
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancy focused on measuring Metastatic solid tumor
Eligibility 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.
Sites / Locations
- Hadassah Medical Organization
Outcomes
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
Full Information
NCT ID
NCT00149032
First Posted
September 7, 2005
Last Updated
April 7, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00149032
Brief Title
Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Official Title
Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Withdrawn
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy, Neoplasm Metastasis
Keywords
Metastatic solid tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
DLI sensitized against antigens expressed by the host.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Upregulating of anti-tumor effects while minimizing anti-host responses
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Slavin, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
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