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ID
Source
Brief title
Health condition
AML, acute myeloid leukemia, acute myeloide leukemie, MDS, myelodysplasia, myelodysplasie, allogeneic stem cell transplantation, allogene stamcel transplantatie, donor lymphocyte infusion, DLI, donor lymfocyten infusie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
This 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).
Study objective
In 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.
Study design
3, 6 and 12 months after transplantation.
Intervention
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 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.
P.A. Borne, von dem
Leiden 2333 ZA
The Netherlands
071-5262267
P.A.von_dem_Borne@lumc.nl
P.A. Borne, von dem
Leiden 2333 ZA
The Netherlands
071-5262267
P.A.von_dem_Borne@lumc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3854 |
| NTR-old | NTR4014 |
| Other | LUMC METC : 2012-02 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |