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An open label randomized controlled study in elderly subjects with previously untreated acute myelogenous leukaemia, comparing treatment groups randomised to receive daunorubicin and cytarabine or daunorubicin, cytarabine and PSC-833.


- candidate number1569
- NTR NumberNTR360
- ISRCTNISRCTN11571826
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsHO31 
- Public TitleAn open label randomized controlled study in elderly subjects with previously untreated acute myelogenous leukaemia, comparing treatment groups randomised to receive daunorubicin and cytarabine or daunorubicin, cytarabine and PSC-833.
- Scientific TitleAn open label randomized controlled study in elderly subjects with previously untreated acute myelogenous leukaemia, comparing treatment groups randomised to receive daunorubicin and cytarabine or daunorubicin, cytarabine and PSC-833.
- ACRONYMHOVON 31 AML / Novartis PSC C 302-E-00
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML)
- Inclusion criteria1. Age >= 60 years;
2. Subjects who have a cytopathologically confirmed diagnosis of previously untreated AML (M0-M2 and M4-M7, FAB classification);
3. Subjects with secondary AML progressing from antecedent MDS are eligible if there has been no previous chemotherapy. Antecedent MDS is defined as any antecedent haematological disease of at least 4 months duration;
4. WHO performance status <= 2;
5. Subjects have given written informed consent.
- Exclusion criteria1. Cytopathologically confirmed CNS infiltration. NB: in the absence of clinical suspicion of CNS involvement, lumbar puncture is not required;
2. Subjects have had previous Polycythemia Rubra Vera, primary myelofibrosis, are in blast cell crisis of chronic myeloid leukaemia or are M3 AML according to FAB classification;
3. Subject has neurosensory toxicity >= Grade 2 (NCIC Expanded CTC);
4. Subject has neurocerebellar toxicity >= Grade 1 (NCIC Expanded CTC);
5. Subject is known to be positive for human immunodeficiency virus (HIV) type 1 antibody (testing to determine HIV antibody status is not necessary to be eligible);
6. Subject has impairment of hepatic or renal function as defined by the following baseline laboratory values:
ALT and/or AST >= 2.5 times IULN
Alkaline phosphatase >= 2.5 times IULN
Serum total bilirubin >= 1.5 times IULN
Serum creatinine >= 1.5 times IULN after adequate hydration;
7. Subject is currently receiving treatment with any of the agents listed in Appendix 11 if treatment cannot be discontinued at the specified time relative to PSC-833 administration. All of the drugs listed are well substantiated to interact with cyclosporin A;
8. Subject has had major surgery within 2 weeks of study entry;
9. Subject has received investigational therapy within 30 days of study entry;
10. Subject has known hypersensitivity to cyclosporin A;
11. Subject has received prior radiotherapy within 4 weeks of study entry;
12. Subject is < 5 years free of another primary malignancy with the exception of basal cell carcinoma of the skin and stage 1 cervical carcinoma;
13. Subject has previously been treated with chemotherapy for AML;
14. Subject has concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension etc.);
15. Subject has a psychological, intellectual or sensory dysfunction which is likely to impede their ability to understand and comply with study requirements;
16. Subject had a myocardial infarction within the last 6 months, has symptomatic ischaemic heart disease, congestive heart failure or other uncontrolled coronary disease.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-mei-1997
- planned closingdate17-feb-1999
- Target number of participants400
- InterventionsPatients with AML, meeting all eligibility criteria will be randomized on entry between:


Arm A: 2 induction cycles of daunorubicin (DNR) 45 mg/m^2/day, days 1-3 and cytarabine (Ara-C) 200 mg/m^2/day, days 1-7;
or


Arm B: 2 induction cycles of DNR 35 mg/m^2/day, days 1-3; Ara-C 200 mg/m^2/day, days 1-7; and PSC-833 loading dose 2 mg/kg over 2 hours, followed by 10 mg/kg/day, days 1-3;


Patients in CR will then be given one consolidation cycle without PSC-833 consisting of Ara-C, mitoxantrone and etoposide.
- Primary outcomeEvent-free survival.
- Secondary outcome1. Complete remission;
2. Disease-free survival;
3. Overall survival;
4. Association between complete remission and expression of P-gp by AML-blasts.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. B. L÷wenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr. B. L÷wenberg
- Sponsor/Initiator Novartis Pharma AG
- Funding
(Source(s) of Monetary or Material Support)
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Novartis Pharma B.V.
- PublicationsB. van der Holt, B. L÷wenberg, A.K. Burnett, W.U. Knauf, J. Shepherd, P.P. Piccaluga, G.J. Ossenkoppele, G.E.G. Verhoef, A. Ferrant, M. Crump, D. Selleslag, M. Theobald, M.F. Fey, E. Vellenga, M. Dugan and P. Sonneveld. The value of the MDR1 reversal agent PSC-833 in addition to daunorubicin and cytarabine in the treatment of elderly patients with previously untreated acute myeloid leukemia (AML), in relation to MDR1 status at diagnosis. Blood, in press. 2005
- Brief summaryStudy phase:
phase III.


Study objective:
evaluation of the effect of PSC-833 during induction treatment with daunorubicin and cytarabine;


Patient population:
patients with untreated AML, age >= 60 years.


Study design:
prospective, multicenter, randomized.


Duration of treatment:
duration of induction and consolidation treatment is maximum 5 months.
- Main changes (audit trail)
- RECORD12-sep-2005 - 15-mei-2008


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