An international collaborative study to discontinue Imatinib/GlivecÂ® in pediatric CML patients with sustained complete molecular response (STOPIMAPED).

An international collaborative study to discontinue Imatinib/GlivecÂ® in pediatric CML patients with sustained complete molecular response.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23324

Enrollment

Registered

2012-05-21

Start date

2012-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CML children stop Imatinib/Glivec® complete molecular response

Interventions

1. Stop Imatinib/Glivec

2. Start Imatinib/Glivec or other inhabitor in case of relapse. Chronic myeloid leukemia is a rare disease in children

SEER databases record an incidence of 2% of all leukemias in children 90%) with molecular relapse experienced this relapse early (<7 months) after stopping Imatinib. All relapsed patients achieved a s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pediatric CML patients treated with Imatinib having achieved and maintained complete molecular remission for at least 2 years; 2. Informed consent needs to be signed.

Exclusion criteria

Exclusion criteria: Non-CML patients, or CML patients with complete cytogenetic reponse but with a moderate molecular response.

Design outcomes

Primary

Measure	Time frame
1. Molecular relapse free survival at 6 and 24 months; 2. Duration of complete molecular remission after stopping Imatinib.	—

Secondary

Measure	Time frame
1. Prognostic studies; 2. Overall survival and survival without progression; 3. Efficacy of restarting Imatinib in a period of 6 months after molecular relapse.	—

Contacts

Public ContactL. Scheffers

Leyweg 299

lscheffers@skion.nl+31 (0)70 3674545

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)