Clinical trial · Interventional
Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria
TRIUMPH: A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
- 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)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eculizumab may prevent leukemia and stop the destruction of red blood cells in patients with paroxysmal nocturnal hemoglobinuria. PURPOSE: This randomized phase III trial is studying how well eculizumab works in treating patients with paroxysmal nocturnal hemoglobinuria.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eculizumab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of paroxysmal nocturnal hemoglobinuria * Must have required ≥ 4 episodes of transfusions for anemia or anemia-related symptoms within the past year * Mean pre-transfusion hemoglobin ≤ 10. 5 g/dL over the past year * Glycosylphosphatidylinositol (GPI)-deficient red blood cell clone (type III cells) of ≥ 10% by flow cytometry * Must have received 1 packed red blood cell transfusion during the study observation period (within 48 hours of the hemoglobin level that precipitated the transfusion) and within 1.5 g/dL of the mean pre-transfusion hemoglobin level over the past year * Pre-transfusion hemoglobin ≤ 9 g/dL with symptoms * Pre-transfusion hemoglobin ≤ 7 g/dL without symptoms * Received Neisseria meningitidis vaccination at least 2 weeks before initiation of study therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics * Absolute neutrophil count \> 500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Lactate dehydrogenase ≥ 1.5 times upper limit of normal Renal * Not specified Immunologic * No known or suspected active bacterial infection * No recurrent bacterial infections * No history of meningococcal disease Other * No known or suspected hereditary complement deficiency * No other condition that would increase the patient's risk or confound the outcome of the study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior bone marrow transplantation * Concurrent epoetin alfa allowed\* Chemotherapy * Not specified Endocrine therapy * Concurrent corticosteroids allowed\*\* Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior participation in another investigational drug trial * More than 30 days since prior investigational agents, devices, or procedures * Concurrent immunosuppressants allowed\* * Concurrent warfarin allowed provided INR level is stable for the past 4 weeks and expected to remain stable during observation and study treatment * Concurrent iron supplements or folic acid allowed\*\* * Concurrent low-molecular weight heparin allowed\*\* NOTE: \*Provided dose is stable for the past 26 weeks and during study observation and treatment NOTE: \*\*Provided dose is stable for the past 4 weeks and expected to remain stable (or decrease for corticosteroids) during study observation and treatment
References
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