HCT Versus CT in Elderly AML

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Procedure: hematopoietic cell transplantation
* Drug: Non-Transplant treatment approach for consolidation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transplant Arm<br>Hematopoietic cell transplantation after Reduced Intensity Conditioning | Procedure: hematopoietic cell transplantation<br>* low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors<br>|
| Active Comparator: Conventional Chemotherapy<br>The non-transplant treatment approach for consolidation | Drug: Non-Transplant treatment approach for consolidation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT |  | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematopoietic cell transplantation, Acute Myeloid Leukemia, first Complete Remission