An open label randomised 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
| ISRCTN | ISRCTN11571826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11571826 |
| Secondary identifying numbers | HO31; NTR360 |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 13/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof B. Löwenberg
Scientific
Scientific
Erasmus Medical Center
Daniel den Hoed Cancer Center
Department of Hematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 4391598 |
|---|---|
| b.lowenberg@erasmusmc.nl |
Study information
| Study design | Multicentre, open label, randomised, active controlled, parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 31 AML/Novartis PSC C 302-E-00 |
| Study objectives | Evaluation of the effect of PSC-833 during induction treatment with daunorubicin and cytarabine. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute myeloid leukaemia (AML) |
| Intervention | Patients with AML, meeting all eligibility criteria will be randomised on entry between: Arm A: two 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: two 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Daunorubicin, cytarabine, PSC-833 |
| Primary outcome measure | Event-free survival |
| Secondary outcome measures | 1. Complete remission 2. Disease-free survival 3. Overall survival 4. Association between complete remission and expression of P-gp by AML-blasts |
| Overall study start date | 12/05/1997 |
| Completion date | 17/02/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Aged greater than or equal to 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. World Health Organization (WHO) performance status less than or equal to 2 5. Subjects have given written informed consent |
| Key exclusion criteria | 1. Cytopathologically confirmed central nervous system (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 greater than or equal to Grade 2 (NCIC Expanded CTC) 4. Subject has neurocerebellar toxicity greater than or equal to 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: 6.1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than or equal to 2.5 times IULN 6.2. Alkaline phosphatase greater than or equal to 2.5 times IULN 6.3. Serum total bilirubin greater than or equal to 1.5 times IULN 6.4. Serum creatinine greater than or equal to 1.5 times IULN after adequate hydration 7. Subject is currently receiving treatment with any of the agents listed in the protocol 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 less than 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 |
| Date of first enrolment | 12/05/1997 |
| Date of final enrolment | 17/02/1999 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Sponsor information
Novartis Pharma AG (Switzerland)
Industry
Industry
-
Basel
CH-4002
Switzerland
"ROR" |
https://ror.org/02f9zrr09 |
|---|
Funders
Funder type
Research organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
No information available
Novartis Pharma B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/10/2005 | Yes | No |
