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Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)
Phase 1 trial testing Erwinase in Relapsed Acute Lymphoblastic Leukemia in 1 participant. Terminated before completion.
| Lead sponsor | Therapeutic Advances in Childhood Leukemia Consortium |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 13 April 2009 |
| Primary completion | 4 June 2010 |
| Estimated completion | 4 June 2010 |
| Sites | 1 location across United States |
Therapeutic Advances in Childhood Leukemia Consortium
Adults 1 to 21, any sex, with Relapsed Acute Lymphoblastic Leukemia or Allergy to PEG e.Coli Asparaginase. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | 0 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Single Arm |
|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Reaction | System | Single Arm |
|---|---|---|
| Agitation | Nervous system disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood fibrinogen | Investigations | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Injection site reaction NOS | Injury, poisoning and procedural complications | — |
| Leukopenia NOS | Blood and lymphatic system disorders | — |
| Neutrophil count | Blood and lymphatic system disorders | — |
| Platelet count decreased | Blood and lymphatic system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Vomiting NOS | Gastrointestinal disorders | — |
Most-reported serious reactions: Hyperglycemia, Hyponatremia.
Data from ClinicalTrials.gov NCT00928200 adverse events section.
This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing