Sequential FLAMSA chemotherapy and T cell depleted reduced intensity conditioning allogeneic stem cell transplantation (TCD FLAMSA-RIC alloSCT) in elderly acute myeloid leukemia and high risk myelodysplasia patients

Phase 2

Recruiting

Conditions: acute myeloid leukemia (AML)
leukemia
myelodysplasia (MDS)
10024324

Registration Number: NL-OMON39744

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

• Patients with AML or high risk MDS
• Not in remission after first intensive induction chemotherapy
• 60-75 years, inclusive
• HLA-identical sibling or unrelated donor completely matched (10/10 for HLA A, B, C, DR, DQ)
• WHO-performance status 0-2
• Written informed consent

Exclusion Criteria

• Previous autologous or allogeneic SCT
• Acute promyelocytic leukemia
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix B);
• Severe cardiac dysfunction (NYHA classification 3-4, see appendix C).
• Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times upper limit of normal);
• Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
• Severe neurological or psychiatric disease;
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Patient known to be HIV-positive

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• The number of patients eligible for DLI at 6 months after transplantation<br /><br>• Incidence of non-hematological grade 3-4 toxicity from the start of<br /><br>chemotherapy until 9 months after transplantation<br /><br>• Incidence of serious adverse events from the start of chemotherapy until 9<br /><br>months after transplantation<br /><br>• Incidence of severe grade 3 or 4 acute GvHD and incidence of extensive<br /><br>chronic GvHD in the first 9 months after transplantation<br /><br>• Non-relapse mortality at 3 and 12 months after transplantation</p><br>

Secondary Outcome Measures