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HCT Versus CT in Elderly AML

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ClinicalTrials.gov Identifier: NCT00766779
Recruitment Status : Terminated (Recommendation of DMC)
First Posted : October 6, 2008
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Acute Leukemia French Association
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
European Organisation for Research and Treatment of Cancer - EORTC
French Innovative Leukemia Organisation
HOVON - Dutch Haemato-Oncology Association
East German Study Group of Hematology and Oncology (OSHO)
Swiss Group for Clinical Cancer Research
Information provided by (Responsible Party):
EBMT, European Group for Blood and Marrow Transplantation

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Procedure: hematopoietic cell transplantation Drug: Non-Transplant treatment approach for consolidation Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT [ Time Frame: 5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766779


Locations
Show Show 48 study locations
Sponsors and Collaborators
EBMT
Acute Leukemia French Association
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
European Organisation for Research and Treatment of Cancer - EORTC
French Innovative Leukemia Organisation
HOVON - Dutch Haemato-Oncology Association
East German Study Group of Hematology and Oncology (OSHO)
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Dietger Niederwieser, Prof EBMT and OSHO
Study Chair: Bob Löwenberg, Prof Stichting Hemato-Oncologie voor Volwassenen Nederland
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Responsible Party: EBMT, Prof Dietger Niederwieser, European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier: NCT00766779    
Other Study ID Numbers: 2007-003514-34
EBMT-ALWP01/2008
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Keywords provided by EBMT, European Group for Blood and Marrow Transplantation:
hematopoietic cell transplantation
Acute Myeloid Leukemia
first Complete Remission
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms