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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Hematological Malignancy Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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DLI sensitized against antigens expressed by the host.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No