Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

BTG

Status and phase

Completed

Phase 2

Conditions

Neoplasms

Treatments

Drug: glucarpidase (50 Units/kg)

Study type

Interventional

Funder types

Other

Identifiers

NCT00219791

PR001-CLN-rpt002

ek.179-6

Details and patient eligibility

About

To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent by patient or legally valid representative
Patients receiving high-dose MTX (>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma)
Age ≥ 18 years
Serum MTX >5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX >1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX >0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine >1.5 × the upper limit of normal (ULN) and/or oliguria (urine output < 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).

Exclusion criteria