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.
- Conditions
- Acute myeloid leukemialeukemia10024324
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- Age >= 60years and <= 75 years
- AML as defined by WHO
- Refractory anaemia 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
- Karnofsky score > 70%
- Written informed consent
- AML FAB M3
- Organ dysfunction
* Patients with creatinine clearance < 50 ml/min
* Cardiac ejection fraction < 40%
* Severe defects in pulmonary function testing 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 < 70%
- Patients with poorly controlled hypertension
- HIV positivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Leukemia-free survival (LFS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Overall survival (median survival if possible; otherwise survival until 40%<br /><br>or 30% alive)<br /><br>- Incidence of relapse<br /><br>- Incidence of myelosuppression (ANC < 500/mm³ for > 2 days, platelets <<br /><br>20,000/mm³ for > 2 days) after initial PBSC infusion<br /><br>- Incidence of aplasia after DLI<br /><br>- Incidence of grades 2-4 acute GvHD after transplant<br /><br>- Incidence of grades 2-4 acute GvHD after DLI<br /><br>- Incidence of grades chronic extensive GvHD after DLI</p><br>