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van CCT (UK)


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van CCT (UK)


6-MP studie.


- candidate number5705
- NTR NumberNTR1811
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mei-2009
- Secondary IDs UMCG Groningen
- Public Title6-MP studie.
- Scientific TitleIdentification of predictive parameters for 6-MP response in AML patients.
- ACRONYM6-MP in AML
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML)
- Inclusion criteria1. Age >18 years;
2. Diagnosed with (relapsing) AML and not eligible for intensive chemotherapy.
- Exclusion criteriaIneligible or not willing to perform the proposed tests.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2008
- planned closingdate1-jun-2011
- Target number of participants18
- InterventionsPeripheral blood and bone marrow cells will be collected before and during treatment with 6-MP.
- Primary outcome1. Expression of multidrug-resistance genes, nuclear receptors and in vitro susceptibity for 6-MP;
2. Changes in the lymphoid compartment during treatment with 6-MP;
3. HLA-type;
4. Clinical response on treatment with 6-MP.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. E. Vellenga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. E. Vellenga
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summary30%-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.
- Main changes (audit trail)
- RECORD7-mei-2009 - 30-sep-2009


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