Clinical trial · Interventional
Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation
A Phase I-II Safety, Tolerability And Pharmacokinetic Study Of Ravuconazole For Prophylaxis Of Invasive Fungal Infections In Patients Undergoing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
NCT00064311CI-TRIAL-00006417completedPhase 1 / Phase 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)
RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation. PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
| Infection | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ravuconazole | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Undergoing a non-myeloablative allogeneic hematopoietic stem cell transplantation * Must be able to start prophylactic antifungal therapy within 48 hours of the transplantation chemotherapy preparative regimen and before the initiation of cyclosporine * No diagnosis of deeply invasive fungal infection based on the MSG/EORTC criteria PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 5 times upper limit of normal (ULN) * AST and ALT no greater than 5 times ULN * Alkaline phosphatase no greater than 5 times ULN Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 4 weeks (12 weeks for males) after study participation * Able to swallow oral medication * Sufficient venous access * No prior anaphylaxis attributed to the azole class of antifungals * No concurrent medical condition that may create an unacceptable additional risk for the patient during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * No concurrent hormonal contraceptives Radiotherapy * Not specified Surgery * Not specified Other * At least 2 weeks since other prior non-FDA approved investigational drugs * No concurrent QTc prolonging medication (e.g., terfenadine, cisapride, quinidine, pimozide, or dofetilide) * No concurrent rifampin * No other concurrent experimental or systemic antifungal therapy * No concurrent agents containing amphotericin B * No other concurrent systemic azole or triazole antifungal agents * No concurrent echinocandins * Concurrent topical antifungals allowed
References
Publications (0)
Data not yet available
No reference posted for this study.