A Randomized Phase III 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 - HCT versus CT elderly AM

Phase 1

• Conditions: Patients with Acute myelogeneous leukemia in complete remission; MedDRA version: 12.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloid

• Registration Number: EUCTR2007-003514-34-FR
• Lead Sponsor: EBMT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-06
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

- Age > or équal 60years and < ou equal 75 years
- AML as defined by WHO
- Refractory anemia with excess of blasts (RAEB)
- primary and secondary AML
- First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols
- Presence of an HLA-identical familiy donor or an unrelated donor (6/6 or 10/10 according to the center policy)
- a male donor is preferred for male recipients
- Karnofsky score > 70 (see appendix D)
- Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- AML FAB M3
- Patients aged > 70 years with a comorbidity score =2 according to the modified charlson comobidity index (Sorror score –see Appendix)
- Organ dysfunction
- Patients with creatinine clearance < 50 ml/min
- Cardiac ejection fraction < 50%
- Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) as defined by the pulmonary consultant, or receiving supplementary continuous oxygen
- Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT - 4x the upper limit of normal
- Karnofsky score £ 60 (see appendix D )
- Patients with poorly controlled hypertension
- HIV positivity
- Treament in other clinical studies with investigational drugs
- Exclusion criteria apply at time of randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate LFS after allogeneic HCT in AML/RAEB in CR using matched or unrelated donors in comparison to conventional chemotherapy;Secondary Objective: To evaluate Overall survival, relapse, Treatment related mortality and complications after Hematopoietic Cell Trnasplantation ;Primary end point(s): - Leukemia free survival (LFS)