Clinical Trial for in Myeloid Leukemia in Children with Down Syndrome

Phase 3

Recruiting

• Conditions: 10024324; Myeloid leukemia

• Registration Number: NL-OMON24912
• Lead Sponsor: German Pediatric Oncology Group (GPOH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Myeloïde leukemie (ML) of Myelodysplastisch Syndroom (MDS), volgens de WHO.

- Trisomie 21: syndroom van Down of mosaic.

Exclusion Criteria

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- Kinderen met ‘Transient Abnormal Myelopoiesis (TAM), volgens de WHO. |

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br><tr><br><td>Event-free survival (EFS), defined as time from diagnosis to the first event or last follow-up. Events are death from any cause, failure to achieve remission, relapse, and secondary malignancy. Failure to achieve remission is considered as an event on day 0.</td><br></tr><br>

Secondary Outcome Measures

Name	Time	Method
<br><tr><br><td>- Overall survival (OS), as defined as the time of diagnosis to death from any cause or last follow-up.<br /><br>- Disease-free survival (DFS)<br /><br>- Early Response Rate (CR, CRp, CRi) after induction<br /><br>- Treatment-related mortality (TRM)<br /><br>- Minimal residual disease (FACS and NGS)<br /><br>- Adverse events (according to NCI CTCAE v4.0)<br /><br>- Duration of myelosuppression (neutrophils &lt; 0.5 Gpt/L).</td><br></tr><br><br>