FLAMSA chemotherapy directly followed by donor stem cell transplantation in elderly patients with acute myeloid leukemia (AML) or high risk myelodysplasia (MDS)
Recruiting
- Conditions
- AML, acute myeloid leukemia, acute myeloide leukemie, MDS, myelodysplasia, myelodysplasie, allogeneic stem cell transplantation, allogene stamcel transplantatie, donor lymphocyte infusion, DLI, donor lymfocyten infusie.
- Registration Number
- NL-OMON22287
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. Patients with AML or high risk MDS (IPSS >= 1.5);
2. Not in remission after first intensive induction chemotherapy (morphologically > 5% blasts in bone marrow aspirate);
Exclusion Criteria
1. Previous autologous or allogeneic SCT;
2. Acute promyelocytic leukemia;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The number of patients eligible for DLI at 6 months after transplantation;<br /><br>2. Incidence of non-hematological grade 3-4 toxicity from the start of chemotherapy until 9 months after transplantation;<br /><br>3. Incidence of serious adverse events from the start of chemotherapy until 9 months after transplantation;<br /><br>4. Incidence of severe overall grade 3 or 4 acute GvHD and incidence of extensive chronic GvHD in the first 9 months after transplantation;<br /><br>5. Non-relapse mortality at 3 and 12 months after transplantation.
- Secondary Outcome Measures
Name Time Method 1. One-year progression free survival after transplantation;<br /><br>2. One-year overall survival after transplantation;<br /><br>3. Quality of life at 3, 6 and 12 months after transplantation in comparison with quality of life at the start of therapy, as determined with the EORTC QLQ-C30 questionnaire.