acute myeloid leukemia and high risk myelodysplasia
Conditions
Interventions
Product Name: Amsacrine
Product Code: RVG 09084
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: AMSACRINE
CAS Number: 51264-14-3
Concentration unit: mg/m2 milligram(s)/square meter
Con
Sponsors
Leiden Universtity Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess feasibility and safety of a sequential treatment regime in which standard intensive chemotherapy (fludarabin-amsacrin-cytarabin) is directly followed by standard allogeneic stem cell transplantation (T cell depleted RIC alloSCT with donor lymphocyte infusion at 3 and 6 months), in elderly patients with AML or high risk myelodysplastic syndrome (IPSS =1.5). • To evaluate the incidence of non-relapse mortality.;Secondary Objective: • To evaluate progression free survival and overall survival;Primary end point(s): • The number of patients eligible for DLI at 6 months after transplantation • Incidence of non-hematological grade 3-4 toxicity from the start of chemotherapy until 9 months after transplantation • Incidence of serious adverse events from the start of chemotherapy until 9 months after transplantation • Incidence of severe grade 3 or 4 acute GvHD and incidence of extensive chronic GvHD in the first 9 months after transplantation • Non-relapse mortality at 3 and 12 months after transplantation;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12 months after stem cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 1-year progression free survival after transplantation • 1-year overall survival after transplantation;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Leiden University Medical Center
Outcome results
None listed