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

H

Hadassah Medical Center

Status and phase

Withdrawn
Phase 2

Conditions

Hematological Malignancy
Neoplasm Metastasis

Treatments

Procedure: DLI sensitized against antigens expressed by the host.

Study type

Interventional

Funder types

Other

Identifiers

NCT00149032
240801-HMO-CTIL

Details and patient eligibility

About

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).

Enrollment

50 estimated patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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