Induction and regulation of a graft-versus-leucemia-effects after allogeneic T-cell depleted stem cell transplantation in patients with chronic myeloic leucemia (CML) and acute leucemia in complete remission by HSV-Tk (Herpes simplex virus thymidin kinase) transduced allogeneic lymphocytes and Ganciclovir-therapy in high-grade GvH (Graft versus Host) disease

Induction and regulation of a graft-versus-leucemia-effects after allogeneic T-cell depleted stem cell transplantation in patients with chronic myeloic leucemia (CML) and acute leucemia in complete remission by HSV-Tk (Herpes simplex virus thymidin kinase) transduced allogeneic lymphocytes and Ganciclovir-therapy in high-grade GvH (Graft versus Host) disease - MHH 2157

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000211

Enrollment

Registered

2010-01-15

Start date

2002-04-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C92

Interventions

Group 1: Conditioning regimen and transplantation: Day -7 to -4: TBI 12 Gy (2x2 Gy/d) (day -7 to -4) Day -3 to -2: Cyclophosphamide 120mg/kg (60mg/kg/d) Day -1 : break Day 0: transplantion (5x105 CD3

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: - Patients with CML in first chronic phase and HLA compatible family or non-family-donor (criteria for donors see below) - Patients with AML or ALL in 1. or 2. remission and HLA compatible family or non-family-donor (criteria for donors see below) - Age 18-55 years - Informed consent Criteria for donors: - Willingness to donate peripheral blood stem cells after informed consenting - Willingness to donate lymphocytes after transplantation

Exclusion criteria

Exclusion criteria: At time of study enrolment: - limited liver function (bilirubin >3mg%) - limited renal function (creatinin >2mg%) - history of cardiac disease (echocardiographically or szintigraphically determined cardiac insufficiency, myocardial infarction 5 x 10e5 CD34+ cells/kg body weight in graft after CD34-selection At time of donor lymphocytes infusion: - II. Grade - Immune suppression with cyclosporine A

Design outcomes

Primary

Measure	Time frame
- Evaluation of safety and efficacy of transfusion of transduced T cells after allogeneic HSCT - Evaluation of graft versus host disease after transfusion of gene modified donor T cells and possibility to treat GVHD with Ganciclovir (GCV). - Evaluation of graft versus leukemia effects using real time PCR for bcr-abl expression	—

Secondary

Measure	Time frame
-engraftment rate, cumulative incidence of grade II-IV acute GvHD, ttime to T cell immune reconstitution and extensive chronic GvHD -incidence and duration of infectious episodes and disease infection mortality -cumulative incidence of relapse (CIR) and disease free survival -acute and longterm toxicity related to HSV-Tk infusions -assess quality of life	—

Countries

Germany

Contacts

Public ContactEva Mischak-Weissinger

Medizinische Hochschule Hannover Hämatologie, Hämostaseologie, Onkologie KMT-Ambulanz

mischak-weissinger.eva@mh-hannover.de+49 511 532-9518

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026