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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149032

Enrollment

Registered

2005-09-08

Start date

2001-08-31

Completion date

Unknown

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancy, Neoplasm Metastasis

Keywords

Metastatic solid tumor

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).

Interventions

PROCEDUREDLI sensitized against antigens expressed by the host.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Upregulating of anti-tumor effects while minimizing anti-host responses	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026