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Virus Therapy
PUL-042 for Blood Cancers
Phase 2
Waitlist Available
Led By Colin Broom, MD
Research Sponsored by Pulmotect, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to understand and give informed consent
Subjects with hematologic malignancies or recipients of hematopoietic stem cell transplantation for specified diagnoses
Must not have
Known history of chronic pulmonary disease, pulmonary hypertension, or heart failure
HSCT recipients in the pre-engraftment period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Summary
This trial aims to test if a new drug called PUL 042 Inhalation Solution can help lessen the severity of lung infections in patients with certain types of cancer and those who have had a stem cell
Who is the study for?
This trial is for patients with blood cancers or who have had a bone marrow transplant and are now suffering from lung infections caused by specific viruses (PIV, hMPV, or RSV). Participants should be diagnosed with these viral infections to qualify.
What is being tested?
The study is testing PUL-042, an experimental drug, against a placebo. It's given as an inhalation solution three times over six days to see if it can lessen the severity of lung infections in the patient group described.
What are the potential side effects?
Since this summary does not provide details on side effects, we can assume that potential side effects may include typical reactions to new medications such as irritation at the site of inhalation, coughing, headaches or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study and can give my consent.
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I have a blood cancer or received a stem cell transplant for certain conditions.
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I haven't had chemotherapy or been on immunosuppressive therapy in the last 6 months.
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I am using birth control and my pregnancy test was negative.
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I am following the required contraception guidelines.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of chronic lung or heart conditions.
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I have had a stem cell transplant and am in the early recovery phase.
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I have previously used PUL-042 Inhalation Solution.
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My blood cancer has returned or is not responding to treatment, and I am expected to live less than 2 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of PUL-042 Inhalation Solution on Lower Respiratory Tract Complications (LRTC)
Secondary study objectives
Change from Pre-Treatment through 28 days
Change in Viral RNA Shedding Relative to Baseline (copies/mL)
Dose/Response
+11 moreSide effects data
From 2021 Phase 2 trial • 101 Patients • NCT043129976%
Nausea
4%
Chest discomfort
4%
Chills
2%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
PUL-042 Inhalation Solution
Sterile Saline for Inhalation
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PUL-042Experimental Treatment1 Intervention
PUL-042 Inhalation Solution
Group II: Sterile Saline for InhalationPlacebo Group1 Intervention
Placebo
Find a Location
Who is running the clinical trial?
Cancer Prevention Research Institute of TexasOTHER
54 Previous Clinical Trials
98,964 Total Patients Enrolled
Pulmotect, Inc.Lead Sponsor
6 Previous Clinical Trials
396 Total Patients Enrolled
Colin Broom, MDPrincipal InvestigatorPulmotect, Inc.
2 Previous Clinical Trials
318 Total Patients Enrolled