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


- candidate number14943
- NTR NumberNTR4014
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2013
- Secondary IDs2012-02  LUMC METC
- Public TitleFLAMSA chemotherapy directly followed by donor stem cell transplantation in elderly patients with acute myeloid leukemia (AML) or high risk myelodysplasia (MDS)
- Scientific TitleSequential 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
- ACRONYMFLAMSA TCD NMA AlloSCT
- hypothesisIn this study we explore the feasibility of the sequential use of FLAMSA chemotherapy and T cell depleted reduced intensity conditioning allogeneic stem cell transplantation followed by donor lymphocyte infusion at 3 and 6 months after transplantation in patients that are not in complete remission after the first induction chemotherapy. This treatment regimen combines an effective chemotherapy regimen (amsacrine-cytarabine) with a relatively non-toxic allogeneic transplantation conditioning regimen and a short time between chemotherapy and the time point of DLI administration (3 months). With this TCD FLAMSA-RIC alloSCT regimen we hope to be able to treat and cure more elderly patients with AML and high risk MDS with allogeneic transplantation.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), Myelodysplasia, Allogeneic stem cell transplantation, Donor lymphocyte infusion
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2013
- planned closingdate1-jun-2016
- Target number of participants15
- InterventionsPatients 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 consists of alemtuzumab in patients transplanted with a related donor and alemtuzumab in combination with rabbit ATG (Thymoglobulin) in patients with an unrelated donor. No further immunosuppressive drugs are given after transplantation. All patients are to be treated with donor lymphocyte infusions at 3 and 6 months after transplantation.
- Primary outcome1. 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 outcome1. 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.
- Timepoints3, 6 and 12 months after transplantation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P.A. Borne, von dem
- CONTACT for SCIENTIFIC QUERIESDr. P.A. Borne, von dem
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThis is a phase 1-2 study to determine feasibility and safety of FLAMSA chemotherapy in combination with T cell depleted reduced intensity conditioning allogeneic stem cell transplantation, followed by donor lymphocyte infusion at 3 and 6 months after transplantation, in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >= 1.5).
- Main changes (audit trail)
- RECORD1-jun-2013 - 1-aug-2013


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