Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma -

Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma - - Special Drug Use Surveillance of Alecensa Capsules in Pediatric Patients- Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039803

Enrollment

Registered

2020-08-03

Start date

2020-08-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pediatric patients with recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma

Exclusion criteria

Exclusion criteria: >14 years old at Alecensa initiation

Design outcomes

Primary

Measure	Time frame
1.Institution information: Name of institution, name of department, date CRF completed, name of physician completing CRF 2.Patient demographics: Patient initials, age at treatment initiation, ID number, sex, reason for use of Alecensa, height, body weight, disease stage, whether recurrent or refractory, B symptoms, performance status, international prognostic index, concurrent disease, previous disease 3.History of previous treatment: Presence or absence, details of treatment, treatment duration (only for the final treatment) 4.Treatment status: Alecensa treatment status (daily dose, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation in patients who discontinued treatment) 5.Response assessment: Date of assessment, assessment 6.Adverse events: Presence or absence, event name, date of onset, worst grade, seriousness, action taken (Alecensa, other), outcome, date of outcome, causal relationship (Alecensa, other factors), laboratory test values 7.<In the case of serious adverse event> Concomitant suspect drug and CYP3A4 inhibitor	—

Measure

Time frame

1.Institution information: Name of institution, name of department, date CRF completed, name of physician completing CRF 2.Patient demographics: Patient initials, age at treatment initiation, ID number, sex, reason for use of Alecensa, height, body weight, disease stage, whether recurrent or refractory, B symptoms, performance status, international prognostic index, concurrent disease, previous disease 3.History of previous treatment: Presence or absence, details of treatment, treatment duration (only for the final treatment) 4.Treatment status: Alecensa treatment status (daily dose, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation in patients who discontinued treatment) 5.Response assessment: Date of assessment, assessment 6.Adverse events: Presence or absence, event name, date of onset, worst grade, seriousness, action taken (Alecensa, other), outcome, date of outcome, causal relationship (Alecensa, other factors), laboratory test values 7.<In the case of serious adverse event> Concomitant suspect drug and CYP3A4 inhibitor

—

Countries

Japan

Contacts

Public ContactAyako Murayama

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

murayamaayk@chugai-pharm.co.jp03-3281-6611

Outcome results