Trial Outcomes & Findings for Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL (NCT NCT01305655)

Last Updated: 2018-09-28

Results Overview

Glucarpidase was used in case of predefined toxic MTX values at defined time points and/or in combination with decreased renal function. A total of 47 patients of the 1286 ALL-patients included in the protocol (3.7 %) were treated with Glucarpidase.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

47 participants

Primary outcome timeframe

6 years 6 months

Results posted on

2018-09-28

Participant Flow

From July 2008 children treated with the NOPHO ALL 2008 protocol (1-18 years) in the Nordic- and Baltic countries received Glucarpidase if they had delayed Mtx elimination in connection HDMTX 5 g/sqr at predefined values.

Participant milestones

Participant milestones
Measure	Glucarpidase Arm In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glucarpidase Arm n=47 Participants In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment. Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is \>250 µM, 36 hour levels \>30 µM or 42 hours levels \>10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.
Age, Categorical <=18 years	47 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	7.5 years STANDARD_DEVIATION 4.89 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment Sweden	14 participants n=5 Participants
Region of Enrollment Norway	16 participants n=5 Participants
Region of Enrollment Finland	1 participants n=5 Participants
Region of Enrollment Denmark	11 participants n=5 Participants
Region of Enrollment Iceland	2 participants n=5 Participants
Region of Enrollment Lithuania	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years 6 months

Outcome measures

Outcome measures
Measure	Glucarpidase Arm n=47 Participants 47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.	47 participants

Adverse Events

Glucarpidase Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jesper Heldrup

NOPHO

Phone: +46705172389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place