To determine predictive parameters for AML patients responsive on 6-MP treatment and to correlate response with changes in lymphocyte subpopulations.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- AML blasts cells will be analyzed for the expression of drug-resistant
parameters, nuclear receptor and the in vitro responsiveness to 6-MP.
- Facs analyses will be performed to define the changes in lymphoid markers
during treatment of 6-MP.
- Treatment response of patients will be defined by improvements in peripheral
blood cell counts and bone marrow composition.
Secondary outcome
Not applicable
Background summary
30%-40% of the patients with acute myeloid leukemia (AML) demonstrate a
clinical response upon treatment with 6-mercaptopurine (6-MP). So far no
predictive parameters have been identified that recognize this subgroup of
patients, but preliminary data suggest an immunological mediated effect that
might be operative in addition to a cytostatic effect.
Study objective
To determine predictive parameters for AML patients responsive on 6-MP
treatment and to correlate response with changes in lymphocyte subpopulations.
Study design
Pilot study. AML patients with relapsing disease and/or not eligible for
intensive chemotherapy will be treated with 6-MP. Before treatment and during
treatment peripheral blood and bone marrow cells will be studied.
Study burden and risks
Additional blood en bone marrow will be collected during regular sampling.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
- age >18 years
- diagnosed with (relapsing) AML not eligible for intensive chemotherapy
Exclusion criteria
Ineligible to perform proposed test
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 |
|---|---|
| CCMO | NL23276.042.08 |