A Phase 2 interventional study of Isavuconazole in Hematologic Malignancy and Myeloproliferative Disorder, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 99 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.
Drug: Isavuconazole
Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
Also known as: Isavuconazonium sulfate
Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT)
Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. Adverse event requiring discontinuation. * The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole.
Time frame: 14 weeks post HCT
Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)
Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. Adverse event requiring discontinuation. * The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole.
Time frame: 26 weeks post HCT
| Milestone | Isavuconazole Prophylaxis |
|---|---|
| Started | 99 |
| Completed | 95 |
| Not completed | 4 |
| Withdrew: Not treated | 4 |
Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. Adverse event requiring discontinuation. * The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole.
| Participants | Isavuconazole Prophylaxis |
|---|---|
| Completed Treatment | 81 |
| Did not complete treatment, breakthrough IFI | 3 |
| Did not complete treatment, discont d/t toxicity | 7 |
| Did not complete treatment, other reasons | 4 |
Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. Adverse event requiring discontinuation. * The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole.
| Participants | Isavuconazole Prophylaxis |
|---|---|
| Completed Study | 89 |
| Did Not Complete Study d/t Death | 6 |
Collected over 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Isavuconazole Prophylaxis | 6/95 (6.3%) | 0/95 (0%) | 7/95 (7.4%) |
| Event | Isavuconazole Prophylaxis |
|---|---|
| HyperbilirubinemiaInvestigations | 3/95 |
| TransaminitisHepatobiliary disorders | 2/95 |
| RashSkin and subcutaneous tissue disorders | 1/95 |
| NauseaGastrointestinal disorders | 1/95 |
| AnemiaBlood and lymphatic system disorders | 1/95 |
| Age, Continuous(years) | Isavuconazole Prophylaxis |
|---|---|
| Median | 57 (26 to 78) |
| Sex: Female, Male(Participants) | Isavuconazole Prophylaxis |
|---|---|
| Female | 31 |
| Male | 64 |
| Ethnicity (NIH/OMB)(Participants) | Isavuconazole Prophylaxis |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 77 |
| Unknown or Not Reported | 9 |
| Race (NIH/OMB)(Participants) | Isavuconazole Prophylaxis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 81 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Isavuconazole Prophylaxis |
|---|---|
| United States | 95 |
| Underlying Disease(Participants) | Isavuconazole Prophylaxis |
|---|---|
| Leukemia | 51 |
| Myelodysplastic syndrome | 15 |
| Lymphoma | 16 |
| Other hematologic malignancy | 13 |
| Graft Manipulation(Participants) | Isavuconazole Prophylaxis |
|---|---|
| Ex vivo T-cell depletion (CD4+ selected) | 31 |
| No graft manipulation | 64 |
| Donor Type(Participants) | Isavuconazole Prophylaxis |
|---|---|
| Matched related | 19 |
| Matched unrelated | 36 |
| Mismatched related/unrelated | 26 |
| Haploidentical | 14 |
3 further baseline measures are reported on the registry.
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center