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

• Conditions: acute myeloid leukemia and high risk myelodysplasia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-004421-24-NL
• Lead Sponsor: eiden Universtity Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-03
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with AML or high risk MDS (IPSS >= 1.5)
• Not in remission after first intensive induction chemotherapy (morphologically > 5% blasts in bone marrow aspirate)
• 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 (see appendix A)
• 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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

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 clinical trial of medicinal product
• Study Design: Not specified