CLOfarabine (Clolar®) Used with DaunoXome® in acute myeloid leukaemia
| ISRCTN | ISRCTN29644734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29644734 |
| Protocol serial number | RG_08-016 |
| Sponsor | University of Birmingham (UK) |
| Funder | Leukaemia Research Fund (UK) |
- Submission date
- 21/10/2008
- Registration date
- 05/02/2009
- Last edited
- 15/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Institute of Child Health
4th Floor, Whittal Street
Birmingham
B6 6NH
United Kingdom
| Phone | +44 (0)121 333 8238 |
|---|---|
| P.R.Kearns@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective non blinded open label phase I dose escalation study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I escalation study of clofarabine (Clolar®) and liposomal daunorubicin (DaunoXome®) in childhood and adolescent acute myeloid leukaemia |
| Study acronym | CLOUD |
| Study objectives | To establish the maximum tolerated dose of clofarabine (Clolar®) when used in combination with DaunoXome®. On 01/03/2011 the anticipated end date was changed from 01/06/2010 to 30/06/2011. |
| Ethics approval(s) | Amended 11/02/2010: West Midlands Research Ethics Committee, 10/02/2009, ref: 08/H1208/36 |
| Health condition(s) or problem(s) studied | Acute myeloid leukaemia |
| Intervention | The calculation of dosage is based on the patients body surface area. The dose of DaunoXome® is fixed for all cohorts at 60 mg/m^2. DaunoXome® is given intravenously over 2 hours and start 4 hours after the start of Clofarabine (Clolar®) on days 1, 3 and 5. The starting dose of Clofarabine (Clolar®) will be 60% of the recommended single agent dose for the paediatric population. Clofarabine (Clolar®) is given intravenously over 2 hours on days 1, 2, 3, 4 and 5. Dose escalations in subsequent cohorts will approximate 33% increments. The following dose levels will be studied: Level -1: 20 mg/m^2/day x 5 days Level 0: 30 mg/m^2/day/ x 5 days Level 1: 40 mg/m^2/day x 5 days Dose escalation will be capped at 40 mg/m^2/day. Patients will receive a single cycle of treatment and will be followed up until day 42. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Clofarabine (Clolar®), daunorubicin (DaunoXome®) |
| Primary outcome measure(s) |
To establish the maximum tolerated dose of clofarabine (Clolar®) when used in combination with DaunoXome®. The maximum tolerated dose will be defined by the number of dose-limiting toxicities during cycle 1 of therapy. |
| Key secondary outcome measure(s) |
1. To characterise the safety and tolerability of the combination of clofarabine (Clolar®) and DaunoXome® including identification of the dose limiting toxicities |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Key inclusion criteria | 1. Diagnosis of acute myelogenous leukaemia (AML) 2. Patients must be in first relapse within 12 months of initial diagnosis or refractory to induction therapy or be in second or subsequent relapse 3. Patients with refractory AML following induction must be greater than 20% blasts in the bone marrow 4. Age must be between 6 months to less than 18 years old, either sex 5. Karnofsky or Lansky score of greater than 50 6. Patients of childbearing potential must have a negative pregnancy test and agree to use an effective birth control or evidence of post-menopausal status. Post-menopausal status is defined as either radiation-induced oophorectomy with last menses greater than 1 year ago; chemotherapy induced menopause with 1 year interval since last menses. 7. Normal renal function 8. Normal hepatic function 9. Cardiac function defined as: shortening fraction of greater than 29% by echocardiogram left ventricular ejection fraction (LVEF) greater than 58% |
| Key exclusion criteria | 1. First relapse greater than 1 year from their initial diagnosis of AML 2. Patients whose previous daunorubicin equivalent exposure equals or exceeds 450 mg/m^2 3. Isolated extramedullary leukaemia 4. Symptomatic central nervous system (CNS) involvement 5. Any evidence of severe or uncontrolled systemic conditions 6. Concurrent treatment or administration of any other experimental drug or with any other cancer therapy 7. Patients unable to be regularly followed up 8. Patient with expected non-compliance to toxicity management guidelines |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
B6 6NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/03/2015: No publications found in PubMed, verifying study status with principal investigator.
