Status:
TERMINATED
Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR
Lead Sponsor:
University Hospital Carl Gustav Carus
Collaborating Sponsors:
German Research Foundation
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01246752
Start Date
February 10 2011
End Date
April 30 2020
Last Update
October 29 2021
Active Locations (19)
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1
Universitätsklinikum Aachen
Aachen, Germany
2
Klinikum Augsburg
Augsburg, Germany
3
Klinikum Chemnitz gGmbH
Chemnitz, Germany
4
University Hospital Carl Gustav Carus
Dresden, Germany, 01307