International randomized phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukemia

Phase 3

Withdrawn

• Conditions: 10024324; relapsed acute myeloid leukemia

• Registration Number: NL-OMON47169
• Lead Sponsor: Stichting Kinderoncologie Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

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 or primary refractory AML
3. Patients with a second or subsequent relapsed AML that were not previously treated according to this particular protocol
4. Signed written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
5. In women of childbearing potential pregnancy must be excluded.
6. Sexually active patients must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria

1. 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 (CTC grade 3 or 4) and/or a Fractional Shortening at echocardiography below 29%
4. A Karnofsky performance status <40% (children * 16 years) or an Lanksy performance status of <40% (children < 16 years) before start of chemotherapy
5. Any other organ dysfunction (CTC grade 4) that will interfere with the administration of the therapy according to this protocol
6. Impaired liver function defined as > than NCI-CTC grade 1 (max 2.0 x ULN for transaminases and bilirubin)
7. History of veno-occlusive disease (VOD)
8. Hypersensitivity to gemtuzumab ozogamicin
9. Inability to potentially complete the treatment protocol for any other reason
10. Pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Bone marrow blasts on *day 28* (before the start of the second reinduction<br /><br>course) given as * 20% or >20%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. overall survival<br /><br>2. event-free survival<br /><br>3. Percentage of patients that achieve CR after two courses of reinduction<br /><br>chemotherapy<br /><br>4. Incidence of treatment related mortality and toxicity according to NCI-CTC<br /><br>criteria</p><br>