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

Phase 3TerminatedNCT01246752

University Hospital Carl Gustav Carus143 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

143

Conditions

Leukemia, Myeloid, Acute

Interventions

Human Stem Cell TransplantationBIOLOGICAL

Human allogenic stem cells

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

Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (19)

Universitätsklinikum Aachen

Aachen, Germany

Klinikum Augsburg

Augsburg, Germany

Outcomes

Primary Outcomes

Percent of Patients alive after 4 years (Overall Survival)

The status of each patient alive/not alive is surveyed every 3 months in year 1+2 and every 6 months in year 3+4 after randomisation.

Time frame: 4 years

Secondary Outcomes

Disease-free survival

Time frame: 4 years

Cumulative incidence of relapse

Time frame: 4 years

Cumulative incidence of non-relapse mortality

Time frame: 4 years

Quality of life assessed by questionnaires

Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health)

Time frame: 4 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.