Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk)

Status:
Terminated

Trial end date:
2020-04-30

Target enrollment:
0

Participant gender:
All

• Status: Terminated
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Carl Gustav Carus
• Collaborator: German Research Foundation
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• AML in first remission

• cytological standard risk, i.e. karyotype not listed under exclusion criteria

• Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)

• age: 18 - 60 years

• medically fit for allogeneic stem cell transplantation

• CR / CRi after induction therapy

Exclusion Criteria:

• core-binding factor leukemia (t(8;21), inv16)

• acute promyelocytic leukemia (t(15;17)

• complex aberrant karyotype

• karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration

• pregnancy / nursing

• non-compliance