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AzTrials

Acute Myeloid LeukemiaPhase 3NCT00766779

HCT Versus CT in Elderly AML

A Phase 3 study testing hematopoietic cell transplantation and Non-Transplant treatment approach for consolidation in people with Acute Myeloid Leukemia, run by European Society for Blood and Marrow Transplantation at 48 sites in 7 countries.

Terminated

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

Official record
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Trial summary

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
hematopoietic cell transplantation and Non-Transplant treatment approach for consolidation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
48 sitesin 7 countries
Study dates
Jan 2010to Dec 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 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60years and ≤ 75 years
  • primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
  • First complete remission following one or two cycles of induction chemotherapy
  • Chemotherapy was administered according to current participating cooperative group protocols
  • Karnofsky score ≥ 70
  • Written informed consent

Who cannot join

  • AML FAB M3
  • HIV positivity
  • Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
  • The second study exclusively concerns induction therapy
  • Consolidation cycle one and two are given according to the accredited study group policy
  • No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
  • Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted

Trial locations and contacts

48 sites in 7 countries.

48 sites in 7 countries

Germany17 sites

  • University Aachen

    Aachen

  • II. Medizinische Klinik, Hämatologie/Internistische Onkologie

    Augsburg

  • Charité - Campus Benjamin Franklin

    Berlin

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • Universitaetsklinikum Dresden

    Dresden

  • Klinik für Innere Medizin C

    Greifswald

  • University of Heidelberg

    Heidelberg

  • Friedrich-Schiller-Universität Jena

    Jena

  • University Hospital

    Leipzig, 04103

  • Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität

    Magdeburg

  • University of Münster

    Münster

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam

  • University Regensburg

    Regensburg

  • Universität Rostock

    Rostock

  • Robert-Bosch-Krankenhaus

    Stuttgart

  • Universität Tübingen

    Tübingen

  • Allogeneic Stem Cell Transplant Cente

    Würzburg

Other trials in Germany

France12 sites

  • Centre Hospitalier Sud Amiens

    Amiens

  • Hopital Femme Enfant Hématologie

    Caen

  • Hôpital d'instruction des armées Percy

    Clamart

  • Centre hospitalier et universitaire (CHU) d´ Estaing

    Clermont-Ferrand

  • Centre hospitalier et universitaire (CHU) de Limoges

    Limoges

  • Institut Paoli-Calmettes

    Marseille

  • CHU de Nantes, Hôtel Dieu

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Centre hospitalier et universitaire (CHU) de Nice

    Nice

  • Hopital Saint Antoine

    Paris 12ème

  • CHU du Haut Lévêque

    Pessac

  • Centre Hospitalier (CH) Saint Quentin

    Saint-Quentin

Other trials in France

Netherlands7 sites

  • Academisch Ziekenhuis bij de Universiteit Amsterdam

    Amsterdam

  • VU University Medical Center Amsterdam

    Amsterdam

  • University Medical Centre Groningen

    Groningen

  • University Hospital Maastricht

    Maastricht

  • Erasmus MC-Daniel den Hoed Cancer Centre

    Rotterdam, 3008

  • University Medical Centre Utrecht

    Utrecht

  • Isala klinieken

    Zwolle

Other trials in Netherlands

Switzerland7 sites

  • Kantonsspital Aarau

    Aarau

  • University Hospital

    Basel, 4031

  • Inselspital Bern

    Bern

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • CHUV Lausanne

    Lausanne

  • Kantonsspital Luzern

    Lucerne

  • University Hospital Zürich

    Zurich

Other trials in Switzerland

Austria2 sites

  • Hanusch Krankenhaus der Wiener Gebietskrankenkasse

    Vienna

  • Medizinische Universität Wien

    Vienna

Other trials in Austria

Belgium2 sites

  • ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen

    Antwerp

  • UZ Gasthuisberg Leuven

    Leuven

Other trials in Belgium

Australia1 site

  • The Alfred Hospital

    Melbourne Victoria

Other trials in Australia

About this study

Official title: Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

Read the detailed description

The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

Being tested
hematopoietic cell transplantation, Non-Transplant treatment approach for consolidation
Keywords
hematopoietic cell transplantation, Acute Myeloid Leukemia, first Complete Remission
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • hematopoietic cell transplantationProcedure or surgery

    low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors

  • Non-Transplant treatment approach for consolidationDrug

    Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.

Study groups in NCT00766779
Study groupRoleWhat they receive
Transplant ArmExperimentalHematopoietic cell transplantation after Reduced Intensity Conditioning
Receives: Procedure: hematopoietic cell transplantation
Conventional ChemotherapyActive comparatorThe non-transplant treatment approach for consolidation
Receives: Drug: Non-Transplant treatment approach for consolidation

What is being measured

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

  1. To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy

    Measured: 5 years

Secondary outcomes (1)

  1. To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT

    Measured: 5 Years

Timeline

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

  1. First posted6 Oct 2008 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2020
  4. Study completionDec 2020

Why it stopped: Recommendation of DMC

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
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00766779
Sponsor's protocol ID
2007-003514-34
Other IDs
EBMT-ALWP01/2008
Status last verified
Oct 2021
First submitted
3 Oct 2008
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hematopoietic cell transplantation and Non-Transplant treatment approach for consolidation in people with Acute Myeloid Leukemia, run by European Society for Blood and Marrow Transplantation at 48 sites in 7 countries.

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 7 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 14 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 48 sites in Germany, France, Netherlands, Switzerland, Austria and 2 more countries. 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: Recommendation of DMC). 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?

To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy (time frame: 5 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 NCT00766779.

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 14 Oct 2021.

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