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

Phase 2

Withdrawn

• Conditions: Hematological Malignancy; Neoplasm Metastasis

• Registration Number: NCT00149032
• Lead Sponsor: Hadassah Medical Organization

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Upregulating of anti-tumor effects while minimizing anti-host responses

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel