Clinical trial · Interventional
Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
A Multicenter, Open, Phase II Study to Estimate the Activity and Safety of Caspofungin (CASP) in the First-Line Treatment of Probable and Proven Invasive Aspergillosis (IA) in Patients With Hematological Malignancies (HM) or Recipients of Autologous Haematopoietic Stem Cell Transplantation and Those With Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
- 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: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant. PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caspofungin acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate as assessed by standard criteria after completion of study treatment
Secondary outcomes (3)
- measure
- Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment
- measure
- Survival rate at 84 days
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of proven or probable invasive aspergillosis (IA) * Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and Aspergillus galactomannan evaluation within 7 days after study entry * Meets any of the following criteria: * Diagnosis of a hematologic malignancy * Underwent autologous or allogeneic hematopoietic stem cell transplantation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 20-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * AST and ALT ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 5 times ULN * Alkaline phosphatase ≤ 5 times ULN * No severe hepatic insufficiency * Child-Pugh score ≤ 9 Renal * No severe renal failure requiring hemodialysis or peritoneal dialysis * Creatinine \< 3.4 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception * No known HIV positivity * No history of allergy or adverse reaction to echinocandin drugs * No known bacterial infection that is not adequately treated * No psychological, familial, social, or geographical condition that would preclude study participation or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Prior empirical antifungal therapy allowed provided treatment duration was ≤ 72 hours * Prior prophylactic oral antifungals allowed * Prior prophylactic IV fluconazole allowed * More than 14 days since prior and no concurrent investigational agents * No prior participation in this study * No prior echinocandins * No other concurrent antifungal therapy
References
Publications (1)
- RESULTViscoli C, Herbrecht R, Akan H, Baila L, Sonet A, Gallamini A, Giagounidis A, Marchetti O, Martino R, Meert L, Paesmans M, Ameye L, Shivaprakash M, Ullmann AJ, Maertens J; Infectious Disease Group of the EORTC. An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients. J Antimicrob Chemother. 2009 Dec;64(6):1274-81. doi: 10.1093/jac/dkp355. Epub 2009 Oct 19. PMID 19841031