Main info

Identificatie:

HOVON 53 AML / OSHO

Sponsor:

HOVON

Included patients:

59

Active sites:

8

(of 10)

Title:

Allografting as Consolidative Immunotherapy for Older Patients with AML in Complete Remission Using Low Dose TBI, PBSC Infusion And Post-Transplant Immunosuppression With Cyclosporine And Mycophenolate Mofetil.

Timeline

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age 50-75 years, inclusive;
• AML as defined by the HOVON/SAKK AML-43 protocol (M0-M2 and M4-M7, FAB classification);
• Refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1,5 (Appendix A);
• AML in first or later CR;
• Have a HLA identical family donor or a HLA identical unrelated donor;
• Karnofsky score > 70 (see appendix B);
• Written informed consent.

Exclusion Criteria:

• AML FAB M3;
• Patients with a creatinine clearance < 50 ml/min;
• Cardiac ejection fraction < 40%;
• 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 E );
• Patients with poorly controlled hypertension;
• HIV positivity;

Participating Sites

= Active hospitals

= Inactive hospitals