Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR

University Hospital Carl Gustav Carus

Status and phase: Terminated; Phase 3

Conditions: Leukemia, Myeloid, Acute

Treatments: Biological: Human Stem Cell Transplantation; Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01246752

TUD-ETAL-1-045

Details and patient eligibility

About

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

Enrollment: 143 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Human Stem Cell Transplantation

Experimental group

Description:

Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor

Treatment:

Biological: Human Stem Cell Transplantation

Consolidating Chemotherapy

Active Comparator group

Description:

Patients receive a standard chemotherapy as consolidation therapy

Treatment:

Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)