Trial intelligence / Profile preview

Allografting and DLI for Older AML Patients in Remission

NCT00005801Phase 2

Key facts

Status: Completed
Start: Nov 1999
Primary completion: Sep 2001
Countries: 1
Sponsor: University of Colorado Denver
Modality: Cell Therapies

Drugs: therapeutic allogeneic lymphocytes
Conditions: acute myeloid leukemia (AML)

Overview

Phase 2, open-label, single-arm trial of therapeutic allogeneic lymphocytes in acute myeloid leukemia (AML), sponsored by University of Colorado Denver. Primary endpoint: Establishment of mixed or full donor chimerism at Day 95. Started Nov 1999; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Nonmyeloablative Transplant + DLI
Low dose TBI followed by PBSC transplant and subsequent DLI

Who it enrols

Older patients (55-75) with AML in first or subsequent complete remission, with an available HLA-identical related donor and adequate organ function.

Endpoints

Primary

Establishment of mixed or full donor chimerismDay 95

Secondary

Conversion from mixed to full donor chimerismPost-DLI
Potential efficacy of regimen

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