Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia

NCT03019939 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2016-0373NCI-2017-00323
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well isavuconazole works in preventing invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia. Isavuconazole may help to prevent invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Neutropenia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)

  Participants with proven or possible invasive fungal infections.

  Up to 100 days from prophylaxis initiation

Secondary Outcomes (10)

• Number of Participants With Invasive Aspergillosis

  Up to 100 days from prophylaxis initiation

• Number of Participants With Other Invasive Fungal Infections (IFIs)

  Up to 100 days from prophylaxis initiation

• Number of Participants With Treatment Success

  Up to 3 years

• Number of Participants Who Failed Treatment

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

Study Arms (1)

Prevention (isavuconazole)

EXPERIMENTAL

Patients receive isavuconazole PO every 8 hours for 6 doses and then Once a day (QD) or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Isavuconazole

Interventions

Isavuconazole DRUG

Given PO or IV

Also known as: BAL8557

Prevention (isavuconazole)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with either newly diagnosed AML or MDS who have either begun (within 4 days of starting study drug) or are planned to begin specific treatment for their AML/MDS; hydroxyurea and cytarabine used for cytoreduction while awaiting initiation of definitive therapy are not considered "specific" treatment; patients who are participating in other therapeutic clinical trials for their AML/MDS may participate in this trial
• Patients must have or be anticipated to have neutropenia (absolute neutrophil count \[ANC\] \< 0.5 x 10\^9/L) (75) for \>= 7 days as a result of treatment of their AML/MDS
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Total bilirubin =\< 3 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 5 x ULN
• Patients must be able to take oral medications, although a brief period of IV therapy (\< 4 days) is permitted at trial entry
• Patients must be willing and able to provide written informed consent for the trial
• Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
• Postmenopausal women must be amenorrheic for \>= 12 months to be considered of non-childbearing potential
• Women and men must continue birth control for the duration of the trial and \>= 3 months after the last dose of study drug
• All WOCBP MUST have a negative pregnancy test prior to first receiving study medication

You may not qualify if:

• Proven, probable or possible IFI within the previous 30 days
• Use of any systemic antifungal therapy for \> 72 hours during the week prior to study drug initiation
• History of hypersensitivity or idiosyncratic reactions to azoles
• Patients with familial short QT syndrome or with corrected QT (QTc) interval =\< 300 ms
• Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued
• Women who are pregnant or nursing, or intend to be/do so during the course of the study
• Patients with severe hepatic impairment (Child-Pugh class C)
• Patients with known or suspected Gilbert's syndrome at the time of study enrollment
• Patients with known gastrointestinal conditions that could potentially interfere with absorption of orally administered medications
• Any condition that, in the opinion of the investigator, may interfere with the objectives of the study, e.g., any condition requiring the use of prohibited drugs or unstable medical conditions other than AML/MDS, such as a cardiac or neurologic disorder expected to be unstable or progressive during the course of the study (e.g., seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia or unstable congestive heart failure, unstable arrhythmias)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Ping Y, Hongmei J, Bellmann C, Ines M, Macmillan T, Webb N, Aram JA, Penack O. A plain language summary on preventing fungal infections with isavuconazole in people with blood-related conditions. Future Microbiol. 2023 Sep;18:861-866. doi: 10.2217/fmb-2022-0280. Epub 2023 Aug 29.

  PMID: 37641932 DERIVED

• Bose P, McCue D, Wurster S, Wiederhold NP, Konopleva M, Kadia TM, Borthakur G, Ravandi F, Masarova L, Takahashi K, Estrov Z, Yilmaz M, Daver N, Pemmaraju N, Naqvi K, Rausch CR, Marx KR, Qiao W, Huang X, Bivins CA, Pierce SA, Kantarjian HM, Kontoyiannis DP. Isavuconazole as Primary Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome: An Open-label, Prospective, Phase 2 Study. Clin Infect Dis. 2021 May 18;72(10):1755-1763. doi: 10.1093/cid/ciaa358.

  PMID: 32236406 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Neutropenia

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Results Point of Contact

• Title: Prithviraj Bose MD/Associate Porfessor
• Organization: The University of Texas MD Anderson Cancer Center

PBose@mdanderson.org

713-792-7747

Study Officials

• Prithviraj Bose

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: March 28, 2017
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: October 26, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-10

Locations

US (1)