HCT Versus CT in Elderly AML

October 6, 2021 updated by: European Society for Blood and Marrow Transplantation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne Victoria, Australia
        • The Alfred Hospital
  • Austria
      • Wien, Austria
        • Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
      • Wien, Austria
        • Medizinische Universität Wien
  • Belgium
      • Antwerpen, Belgium
        • ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
      • Leuven, Belgium
        • UZ Gasthuisberg Leuven
  • France
      • Amiens cedex 1, France
        • Centre Hospitalier Sud Amiens
      • Caen Cedex 9, France
        • Hopital Femme Enfant Hématologie
      • Clamart, France
        • Hôpital d'Instruction des Armées Percy
      • Clermont-Ferrand, France
        • Centre hospitalier et universitaire (CHU) d´ Estaing
      • Limoges cedex, France
        • Centre hospitalier et universitaire (CHU) de Limoges
      • Marseille cedex 9, France
        • Institut Paoli-Calmettes
      • Nantes cedex 01, France
        • CHU de Nantes, Hôtel Dieu
      • Nice, France
        • Centre hospitalier et universitaire (CHU) de Nice
      • Nice cedex 2, France
        • Centre Antoine Lacassagne
      • Paris 12ème, France
        • Hôpital Saint Antoine
      • Pessac, France
        • CHU du Haut Leveque
      • Saint Quentin cedex, France
        • Centre Hospitalier (CH) Saint Quentin
  • Germany
      • Aachen, Germany
        • University Aachen
      • Augsburg, Germany
        • II. Medizinische Klinik, Hämatologie/Internistische Onkologie
      • Berlin, Germany
        • Charite - Campus Benjamin Franklin
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany
        • Universitaetsklinikum Dresden
      • Greifswald, Germany
        • Klinik für Innere Medizin C
      • Heidelberg, Germany
        • University of Heidelberg
      • Jena, Germany
        • Friedrich-Schiller-Universität Jena
      • Leipzig, Germany, 04103
        • University Hospital
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
      • Münster, Germany
        • University of Munster
      • Potsdam, Germany
        • Klinikum Ernst von Bergmann gGmbH
      • Regensburg, Germany
        • University Regensburg
      • Rostock, Germany
        • Universität Rostock
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus
      • Tübingen, Germany
        • Universitat Tubingen
      • Würzburg, Germany
        • Allogeneic Stem Cell Transplant Cente
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Ziekenhuis bij de Universiteit Amsterdam
      • Amsterdam, Netherlands
        • VU University Medical Center Amsterdam
      • Groningen, Netherlands
        • University Medical Centre Groningen
      • Maastricht, Netherlands
        • University Hospital Maastricht
      • Rotterdam, Netherlands, 3008
        • Erasmus MC-Daniel den Hoed Cancer Centre
      • Utrecht, Netherlands
        • University Medical Centre Utrecht
      • Zwolle, Netherlands
        • Isala Klinieken
  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital Aarau
      • Basel, Switzerland, 4031
        • University Hospital
      • Bern, Switzerland
        • Inselspital Bern
      • Geneve, Switzerland, 1211
        • Hôpitaux Universitaires de Genève
      • Lausanne, Switzerland
        • CHUV Lausanne
      • Luzern 16, Switzerland
        • Kantonsspital Luzern
      • Zürich, Switzerland
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transplant Arm
Hematopoietic cell transplantation after Reduced Intensity Conditioning
Procedure: hematopoietic cell transplantation
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
Active Comparator: Conventional Chemotherapy
The non-transplant treatment approach for consolidation
Drug: Non-Transplant treatment approach for consolidation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Society for Blood and Marrow Transplantation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Organisation for Research and Treatment of Cancer - EORTC
Swiss Group for Clinical Cancer Research
French Innovative Leukemia Organisation
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Acute Leukemia French Association
HOVON - Dutch Haemato-Oncology Association
East German Study Group of Hematology and Oncology (OSHO)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dietger Niederwieser, Prof, EBMT and OSHO
  • Study Chair: Bob Löwenberg, Prof, Stichting Hemato-Oncologie voor Volwassenen Nederland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-003514-34
  • EBMT-ALWP01/2008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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