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Treatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia.


- candidate number14615
- NTR NumberNTR3927
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mrt-2013
- Secondary IDsNL43828.029.13 / 2013-000238-37; CCMO / EUDRACT
- Public TitleTreatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia.
- Scientific TitleTreatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia.
- ACRONYM
- hypothesisto decrease the cumulative incidence of (hematological) relapse.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), Allogeneic stem cell transplantation, Minimal residual disease
- Inclusion criteria1. Patients with Acute Myeloid Leukemia according to WHO classification 2008;
2. Age 18-75;
3. Indication for allogeneic stem cell transplantation based on risk group profile;
4. Related or unrelated 8/8 HLA matched donor available;
5. Presence of Leukemia Associated Phenotype(s);
6. Written informed consent.
- Exclusion criteria1. Myelodysplastic syndrome with refractory anaemia with excess blasts (RAEB);
2. Acute Promyelocytic Leukemia (AML M3);
3. Absence of LAP(s);
4. Previous allogeneic stem cell transplantation;
5. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
6. Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
7. Severe neurological or psychiatric disease;
8. Significant hepatic dysfunction (serum bilirubin or transaminases => 3 times upper limit of normal) unless related to treatment;
9. Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
10. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
11. Patient known to be HIV-positive;
12. Pregnant or breast-feeding female patients;
13. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2013
- planned closingdate1-apr-2015
- Target number of participants31
- InterventionsBased on MRD immune suppressive therapy consisting of Mycophenolate Mofetil and Cyclosporine A will be withdrawn early compared to standard practise. Duration of Ciclosporine A and Mycophenolate Mofetil is dependent on MDR-outcome and the presence of Graft versus Host disease. Mycophenolate Mofetil will be given for a maximum of 84 days and Ciclosporine A for 180 days. There will be no control group.
- Primary outcomeCumulative incidence of (hematological) relapse.
- Secondary outcome1. Relapse free survival;
2. Overall survival;
3. Incidence of acute and chronic GVHD.
- TimepointsEvery 4 weeks starting from baseline until day +168.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr. E. Meijer
- CONTACT for SCIENTIFIC QUERIESDr. E. Meijer
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryBackground of the study:
MRD has shown high prognostic value before and after allogeneic transplantation in AML for predicting relapse. It seems likely that using MRD for therapeutic intervention will reduce cumulative incidence of relapse.

Objective of the study:
To decrease the cumulative incidence of (hematological) relapse.

Study design:
Phase II monocenter study.

Study population:
Patients with AML and a leukemia associated phenotype who will undergo an allogeneic stem cell transplantation.

Intervention:
Based on MRD immune suppressive therapy consisting of Mycophenolate Mofetil and Cyclosporine A will be withdrawn early compared to standard practise.

Primary study parameters/outcome of the study:
The cumulative incidence of (hematological) relapse.

Secundary study parameters/outcome of the study:
1. Relapse free survival;
2. Overall survival;
3. Incidence of acute and chronic GVHD.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
no extra punctions will be done, only extra withdrawal of blood and bonemarrow on standard timepoints.
Risk of earlier graft versus host disease after earlier tapering/stop of immunosupressiva, but justified by lowering the cumulative incidence of relapse.
- Main changes (audit trail)
- RECORD28-mrt-2013 - 11-dec-2013


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