FLAMSA chemotherapy directly followed by donor stem cell transplantation in elderly patients with acute myeloid leukemia (AML) or high risk myelodysplasia (MDS)

Sequential FLAMSA chemotherapy and T cell depleted reduced intensity conditioning allogeneic stem cell transplantation with postponed donor lymphocyte infusion in elderly acute myeloid leukemia and high risk myelodysplasia patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22287

Enrollment

Registered

2013-06-01

Start date

2013-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Patients will receive FLAMSA chemotherapy over the course of 5 days. After a 3 day rest, the conditioning of the allogeneic stem cell transplantation is started. T cell depletion of the patient consis

Eligibility

Inclusion criteria

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); 3. 60-75 years, inclusive; 4. HLA-identical sibling or unrelated donor completely matched (10/10 for HLA A, B, C, DR, DQ); 5. WHO-performance status 0-2; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous autologous or allogeneic SCT; 2. Acute promyelocytic leukemia; 3. Severe pulmonary dysfunction (CTCAE grade III-IV); 4. Severe cardiac dysfunction (NYHA classification 3-4); 5. Significant hepatic dysfunction (serum bilirubin or transaminases (>= 3 times upper limit of normal); 6. Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration); 7. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.); 8. Severe neurological or psychiatric disease; 9. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 10. Patient known to be HIV-positive.

Design outcomes

Primary

Measure	Time frame
1. The number of patients eligible for DLI at 6 months after transplantation; 2. Incidence of non-hematological grade 3-4 toxicity from the start of chemotherapy until 9 months after transplantation; 3. Incidence of serious adverse events from the start of chemotherapy until 9 months after transplantation; 4. Incidence of severe overall grade 3 or 4 acute GvHD and incidence of extensive chronic GvHD in the first 9 months after transplantation; 5. Non-relapse mortality at 3 and 12 months after transplantation.	—

Measure

Time frame

1. The number of patients eligible for DLI at 6 months after transplantation; 2. Incidence of non-hematological grade 3-4 toxicity from the start of chemotherapy until 9 months after transplantation; 3. Incidence of serious adverse events from the start of chemotherapy until 9 months after transplantation; 4. Incidence of severe overall grade 3 or 4 acute GvHD and incidence of extensive chronic GvHD in the first 9 months after transplantation; 5. Non-relapse mortality at 3 and 12 months after transplantation.

—

Secondary

Measure	Time frame
1. One-year progression free survival after transplantation; 2. One-year overall survival after transplantation; 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.	—

Contacts

Public ContactP.A. Borne, von dem

Leids Universitair Centrum, Afdeling Hematologie C2-R, Albinusdreef 2

P.A.von_dem_Borne@lumc.nl071-5262267

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)