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

Neoplasm Metastasis Clinical Trial

Official title:

Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00149032
• Other study ID #: 240801-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: April 7, 2011
• Start date: August 2001

Study information

• Verified date: September 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematological Malignancy
• Neoplasm Metastasis

Intervention

Procedure:
• DLI sensitized against antigens expressed by the host.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Upregulating of anti-tumor effects while minimizing anti-host responses