To decrease the cumulative incidence of (hematological) relapse
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The cumulative incidence of (hematological) relapse
Secondary outcome
*Relapse free survival
*Overall survival
*Incidence of acute and chronic GVHD
Background summary
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.
Study objective
To decrease the cumulative incidence of (hematological) relapse
Study design
Phase II monocenter study
Intervention
Based on MRD immune suppressive therapy consisting of Mycophenolate Mofetil and
Cyclosporine A will be withdrawn early compared to standard practise.
Study burden and risks
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
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
*Patients with Acute Myeloid Leukemia according to WHO classification 2008
*Age 18-75
*Indication for allogeneic stem cell transplantation based on risk group profile
*Related or unrelated 8/8 HLA matched donor available
*Presence of Leukemia Associated Phenotype(s) (LAPs)
*Written informed consent
Exclusion criteria
-Myelodysplastic syndrome with refractory anaemia with excess blasts (RAEB)
Acute Promyelocytic Leukemia (AML M3)
-Absence of LAP(s)
-Previous allogeneic stem cell transplantation
-Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
*Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
*Severe neurological or psychiatric disease
*Significant hepatic dysfunction (serum bilirubin or transaminases * 3 times upper limit of normal) unless related to treatment
*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.)
*Patient known to be HIV-positive
*Pregnant or breast-feeding female patients
*Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000238-37-NL |
| CCMO | NL43828.029.13 |
| Other | NTR |
| OMON | NL-OMON27188 |