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

NCT01246752 | Terminated Phase 3 DMC

• 1 other identifier: TUD-ETAL-1-045
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 19

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

Conditions

Leukemia, Myeloid, Acute

Keywords

AML, Leukemia; Acute Myeloid Leukemia; HSCT; Stem Cell Transplantation; Tx; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (4)

• Disease-free survival

  4 years

• Cumulative incidence of relapse

  4 years

• Cumulative incidence of non-relapse mortality

  4 years

• Quality of life assessed by questionnaires

  4 years

Study Arms (2)

Human Stem Cell Transplantation

EXPERIMENTAL

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

Biological: Human Stem Cell Transplantation

Consolidating Chemotherapy

ACTIVE COMPARATOR

Patients receive a standard chemotherapy as consolidation therapy

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

Interventions

Human Stem Cell Transplantation BIOLOGICAL

Human allogenic stem cells

Human Stem Cell Transplantation

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

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

Consolidating Chemotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• AML in first remission

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital Carl Gustav Carus: lead
• German Research Foundation: collaborator

Study Sites (19)

Universitätsklinikum Aachen

Aachen, Germany

Location

Klinikum Augsburg

Augsburg, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Location

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Universitätsklinikum Essen - Westdeutsches Tumorzentrum

Essen, Germany

Location

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universität

Frankfurt am Main, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Universitaetsklinikum Leipzig - AöR

Leipzig, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Marburg, Germany

Location

Klinikum der LMU Universität - Campus Großhadern

München, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Städtisches Klinikum Nord

Nuremberg, Germany

Location

Ernst-von-Bergmann-Klinikum Potsdam

Potsdam, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Location

Related Publications (1)

• Bornhauser M, Schliemann C, Schetelig J, Rollig C, Kramer M, Glass B, Platzbecker U, Burchert A, Hanel M, Muller LP, Klein S, Bug G, Beelen D, Rosler W, Schafer-Eckart K, Schmid C, Jost E, Lenz G, Tischer J, Spiekermann K, Pfirrmann M, Serve H, Stolzel F, Alakel N, Middeke JM, Thiede C, Ehninger G, Berdel WE, Stelljes M. Allogeneic Hematopoietic Cell Transplantation vs Standard Consolidation Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2023 Apr 1;9(4):519-526. doi: 10.1001/jamaoncol.2022.7605.

  PMID: 36757706 DERIVED

Related Links

• Study Alliance Leukemia (coordinating study group)

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

Consolidation Chemotherapy; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Martin Bornhaeuser, Prof. (MD)

  Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: February 10, 2011
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

DE (19)