International study to confirm a benefit of a combination of anti-cancer drugs in the treatment of children and young patients under age of 21 years with refractory or recurrent acute blood cancer

• Conditions: Pediatric relapsed or refractory AML; MedDRA version: 16.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-018980-41-HU
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Children and adolescents < 18 years of age at start of initial chemotherapy and < 21 years of age at start of this relapsed AML treatment
2. Patients with first relapsed (including relapse after SCT) or primary refractory AML
3. Signed written informed consent from patients and/or from parents or legal guardians for minor patients, according to local law and regulations
4. In female patients of childbearing potential pregnancy must be excluded.
5. Sexually active patients must be using two reliable contraception methods from the time of screening/baseline and during the study for a minimum of 3 months after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

1. Acute promyeloblastic leukemia (AML FAB type M3; please refer to your local group for the appropriate treatment protocol)
2. Myeloid Leukemia of Down syndrome (please refer to your local group for treatment alternatives)
3. Symptomatic cardiac dysfunction (CTCAEv4 grade 3 or 4) and/or a Fractional Shortening at echocardiography below 29%
4. A Karnofsky performance status < 40% (children = 16 years) or an Lansky performance status of < 40% (children < 16 years) before start of chemotherapy
5. Any other organ dysfunction (CTCAEv4 grade 4) that will interfere with the administration of the therapy according to this protocol
6. Impaired liver function defined as > 3.0 x UNL for transaminases and for bilirubin
7. History of VOD
8. History hepatitis C positivity
9. Renal impairment with creatinine < 30 ml/min
10. Decompensated hemolytic anemia
11. Hypersensitivity to GO and/or other chemotherapeutic drugs
12. Inability to potentially complete the treatment protocol for any other reason
13. Pregnant or breastfeeding patients
14. Current participation in another clinical trial for the time of first course of reinduction chemotherapy

Study & Design

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