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HSV-Tk–transduced donor lymphocyte infusion after T-cell–depleted allogeneic stem cell transplantation in leukemia

DRKS00000211Phase 2

Key facts

Status
Completed
Start
Jan 2010
Countries
1
Sponsor
Medizinische Hochschule Hannover
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, DNA Intercalators/Alkylators → Nucleic Acid-Directed Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
Conditions
chronic myelogenous leukemia (CML)Acute Leukaemia
01

Overview

Phase 2, open-label, single-arm trial of ganciclovir in chronic myelogenous leukemia (CML) and Acute Leukaemia, sponsored by Medizinische Hochschule Hannover. Started Jan 2010; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • HSV-Tk–transduced donor lymphocyte infusion + conditional ganciclovir after T-cell–depleted allogeneic SCT

    Single-arm cohort receiving standard myeloablative conditioning with total body irradiation and cyclophosphamide followed by T-cell–depleted allogeneic stem cell transplantation, then HSV-Tk–transduced donor lymphocyte infusion; ganciclovir is started only if patients develop grade II–IV…

03

Who it enrols

Patients with chronic myeloid leukemia or acute leukemia in complete remission following T-cell–depleted allogeneic stem cell transplantation, candidates for donor lymphocyte infusion with HSV-Tk–transduced allogeneic lymphocytes and potential ganciclovir treatment in case of grade II–IV graft-versus-host disease.

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