Clinical trial · Interventional
Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance
Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage
NCT00219791CI-TRIAL-00015586completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| glucarpidase (50 Units/kg) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Reduction in serum MTX concentration
Secondary outcomes (9)
- measure
- serum blood-urea-nitrogen
- measure
- serum creatinine
- measure
- creatinine clearance
- measure
- haematology (complete blood count and differential)
- measure
- biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)
- measure
- urinalysis (dip-stick)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * Pregnant or lactating females * Unwillingness of patient or relative/legal representative to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.