Phase I Dose Escalation Study of Clofarabine and Liposomal Daunorubicin in Childhood and Adolescent AML - CLOUD

Phase 1

• Conditions: Paediatric patients (6 months to 18 years) diagnosed with AML who are refractory to front line therapy, early first relapse (less than 1 year from diagnosis) and second and subsequent relapse patients.; MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia; MedDRA version: 9.1 Level: LLT Classification code 10066764 Term: Acute myeloid leukaemia progression

• Registration Number: EUCTR2008-002288-14-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-31
• Study Completion: 2011-10-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Diagnosis of acute myelogenous leukaemia (AML).
- Patients must be in first relapse within 12 months of initial diagnosis or refractory to induction therapy or be in second or subsequent relapse.
- Patients in first or subsequent relapse must have = 5% blasts in the bone marrow, with or without extramedullary disease AND immunophentypic confirmation of AML.
- Patients with refractory AML following induction must have > 20% blasts in the bone marrow.
- Age must be between 6 months to 18 years old.
- Karnofsky or Lansky score of = 50
- Patients of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method or evidence of post-menopausal status. Post-menopausal status is defined as either radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses.
- Normal renal function defined as Serum creatinine based on normal range for age/gender
- Normal hepatic function defined as: Total bilirubin NORMAL for age. ALT OR AST < 5 x upper limit of normal (ULN) for age (unless it is known to be related to leukaemic involvement).
- Cardiac function defined as: shortening fraction of = 29% by echocardiogram LVEF > 58%

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- First relapse > 1 year from their initial diagnosis of AML
- Patients whose previous daunorubicin equivalent exposure equals or exceeds 450mg/m2.
- Isolated extramedullary leukemia.
- Symptomatic CNS-involvement.
- Any evidence of severe or uncontrolled systemic conditions (e.g., systemic infection) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- Concurrent treatment or administration of any other experimental drug or with any other anti-cancer therapy.
- Patients unable to be regularly followed up for psychological, social, family or geographic reasons.
- Patient with expected non-compliance to toxicity management guidelines

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified