A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission. - HOVON 93 AML/HCT vs CT elderly AML

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39855

Enrollment

Registered

2009-02-23

Start date

2010-01-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Acute myeloid leukemia leukemia

Interventions

Patients with a donor will be randomized between standard treatment and treatment with Fludarabine, 200 cGy TBI and allogeneic HCT followed by immunosuppression with CyA and MMF. For patients of 60-

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 60years and 70% - Written informed consent

Exclusion criteria

Exclusion criteria: - AML FAB M3 - Organ dysfunction * Patients with creatinine clearance 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal - Karnofsky score

Design outcomes

Primary

Measure	Time frame
Leukemia-free survival (LFS)	—

Secondary

Measure	Time frame
- Overall survival (median survival if possible; otherwise survival until 40% or 30% alive) - Incidence of relapse - Incidence of myelosuppression (ANC 2 days, platelets 2 days) after initial PBSC infusion - Incidence of aplasia after DLI - Incidence of grades 2-4 acute GvHD after transplant - Incidence of grades 2-4 acute GvHD after DLI - Incidence of grades chronic extensive GvHD after DLI	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)