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Leukemia, Myeloid, AcutePhase 3AMLNCT01246752

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

A Phase 3 study testing Human Stem Cell Transplantation and Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC) in people with Leukemia, Myeloid, Acute, run by University Hospital Carl Gustav Carus at 19 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Human Stem Cell Transplantation and Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
19 sitesGermany
Study dates
10 Feb 2011to 30 Apr 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

19 sites in 1 country.

19 sites in 1 country

Germany19 sites

  • Universitätsklinikum Aachen

    Aachen

  • Klinikum Augsburg

    Augsburg

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • University Hospital Carl Gustav Carus

    Dresden, 01307

  • Universitätsklinikum Erlangen

    Erlangen

  • Universitätsklinikum Essen - Westdeutsches Tumorzentrum

    Essen

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder)

  • Klinikum der Johann-Wolfgang-Goethe Universität

    Frankfurt am Main

  • Universitätsklinikum Halle

    Halle

  • Asklepios Klinik St. Georg

    Hamburg

  • Universitaetsklinikum Leipzig - AöR

    Leipzig

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsklinikum Mannheim

    Mannheim

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg

  • Klinikum der LMU Universität - Campus Großhadern

    München

  • Universitätsklinikum Münster

    Münster

  • Städtisches Klinikum Nord

    Nuremberg

  • Ernst-von-Bergmann-Klinikum Potsdam

    Potsdam

  • Robert-Bosch-Krankenhaus

    Stuttgart

Other trials in Germany

About this study

Official title: Randomised Trial on Allogeneic Haematopoietic Stem Cell Transplantation in Patients Under the Age of 60 Years With Acute Myeloid Leukemia of Intermediate Risk in First Complete Remission and a Matched Sibling or Unrelated Donor (ETAL-1)

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

Being tested
Human Stem Cell Transplantation, Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Keywords
AML, Leukemia, Acute Myeloid Leukemia, HSCT, Stem Cell Transplantation, Tx, Chemotherapy
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT01246752
Study groupRoleWhat they receive
Human Stem Cell TransplantationExperimentalPatients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
Receives: Biological: Human Stem Cell Transplantation
Consolidating ChemotherapyActive comparatorPatients receive a standard chemotherapy as consolidation therapy
Receives: Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

Secondary outcomes (4)

  1. Disease-free survival

    Measured: 4 years

  2. Cumulative incidence of relapse

    Measured: 4 years

  3. Cumulative incidence of non-relapse mortality

    Measured: 4 years

  4. 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)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2010 (estimated)
  2. Study start10 Feb 2011
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Why it stopped: decreased recrucial rate as the likelihood of achieving the envisioned patient number in a realistic time-frame was very low.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01246752
Sponsor's protocol ID
TUD-ETAL-1-045
Acronym
AML
Status last verified
Oct 2021
First submitted
22 Nov 2010
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36757706

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human Stem Cell Transplantation and Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC) in people with Leukemia, Myeloid, Acute, run by University Hospital Carl Gustav Carus at 19 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: decreased recrucial rate as the likelihood of achieving the envisioned patient number in a realistic time-frame was very low.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Patients alive after 4 years (Overall Survival) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01246752, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.

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