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Acute Myeloid LeukemiaPhase 2NCT03019939

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

A Phase 2 study testing Isavuconazole in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Isavuconazole
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
28 Mar 2017to 10 Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess whether prophylaxis with isavuconazole effectively prevents the occurrence of proven or probable invasive fungal infections (IFIs) in patients with newly diagnosed acute myeloid leukemia/myelodysplastic syndrome (AML/MDS) receiving successive cycles of intensive chemotherapy or other therapies for up to 100 days from prophylaxis initiation.

SECONDARY OBJECTIVES:

  1. To evaluate the incidence of invasive aspergillosis (IA) within 100 days of beginning isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or other therapies.

II. To evaluate the incidence of other IFIs within 100 days of beginning isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or other therapies.

III. To evaluate the composite outcome of treatment success versus (vs.) failure in this patient population.

IV. To measure the overall survival (OS) of study participants. V. To measure the IFI-free survival of study participants. VI. To document the time to death from any cause in the study population. VII. To document the time to death related to IFI in the study population. VIII. To document the time to diagnosis of proven or probable IFI in the study population.

IX. To document the time to initiation of empiric anti-fungal therapy in the study population.

  1. To characterize the safety, tolerability and adverse event (AE) profile of isavuconazole in the prophylactic setting.

EXPLORATORY OBJECTIVES:

  1. To assess the potential role, if any, of therapeutic drug monitoring (TDM) of isavuconazole levels in the prophylactic setting in patients with newly diagnosed AML/MDS receiving cytotoxic chemotherapy or other therapies.

II. To determine the in vitro susceptibility of agents causing "breakthrough" IFIs to antifungal agents.

OUTLINE:

Patients receive isavuconazole orally (PO) every 8 hours for 6 doses and then once daily (QD) or intravenously (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.

Being tested
Isavuconazole
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsavuconazoleDrug

    Also called BAL8557

    Given PO or IV

Study groups in NCT03019939
Study groupRoleWhat they receive
Prevention (isavuconazole)ExperimentalPatients 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.
Receives: Drug: Isavuconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Participants with proven or possible invasive fungal infections.

    Measured: Up to 100 days from prophylaxis initiation

Secondary outcomes (10)

  1. Number of Participants With Invasive Aspergillosis

    Participants with invasive aspergillosissured.

    Measured: Up to 100 days from prophylaxis initiation

  2. Number of Participants With Other Invasive Fungal Infections (IFIs)

    Participants with other IFIs will be measured.

    Measured: Up to 100 days from prophylaxis initiation

  3. Number of Participants With Treatment Success

    Will evaluate versus (vs.) failure (defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).

    Measured: Up to 3 years

  4. Number of Participants Who Failed Treatment

    Will evaluate versus success. Success is defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).

    Measured: Up to 3 years

  5. Overall Survival (OS)

    Time from date of treatment start until date of death due to any cause or last Follow-up.

    Measured: Up to 3 years

  6. Invasive Fungal Infections (IFIs)-Free Survival

    Time measured in days from start of treatment to IFI or off study date

    Measured: Up to 3 years

  7. Time to Death From Any Cause

    Time to death from any cause will be measured.

    Measured: Up to 3 years

  8. Number of Participants With Death Related to Invasive Fungal Infections (IFIs)

    Death's from invasive fungal infections

    Measured: Up to 3 years

  9. Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)

    Time measured in days from start of treatment to invasive fungal infections

    Measured: Up to 3 years

  10. Time to Initiation of Empiric Anti-fungal Therapy

    Time days from start of empiric anti-fungal therapy.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study start28 Mar 2017
  3. Primary completion10 Aug 2020
  4. Study completion10 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03019939
Sponsor's protocol ID
2016-0373
Other IDs
NCI-2017-00323, 2016-0373
Status last verified
Oct 2021
First submitted
11 Jan 2017
Last updated
26 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37641932

  • 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.

    PubMed 32236406

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isavuconazole in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs) (time frame: Up to 100 days from prophylaxis initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03019939, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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