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Pegylated Interferon Alfa-2a for Myelofibrosis (ATIOM Trial)
Phase 1
Recruiting
Led By Sagar Patel, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for myelofibrosis after allogeneic stem cell transplantation. The trial will assess how well the treatment is tolerated and what the recommended dose is for future trials.
Who is the study for?
This trial is for adults over 18 with primary or secondary myelofibrosis who are eligible for a bone marrow transplant. They must be physically able to undergo the procedure, have a perfect match donor, and women must be post-menopausal or surgically sterile.
What is being tested?
The study tests Pegylated interferon alpha2a in patients after bone marrow transplantation. It's an open-label Phase 1 trial focusing on finding the safest dose that doesn't cause too many side effects (dose-limiting toxicities).
What are the potential side effects?
Possible side effects of Pegylated interferon alpha2a include flu-like symptoms, tiredness, changes in blood counts and mood swings. The exact side effects will be closely monitored during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Secondary study objectives
Assess Objective Response Rate (ORR) in the study population.
Assess leukemia-free survival (LFS) in the study population.
Assess the incidence of acute and/or chronic graft versus host disease (GVHD) in the study population
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: All PatientsExperimental Treatment1 Intervention
A 3+3 dose de-escalation design will be used to determine the recommended phase 2 dose,while ensuring the safety and tolerability of the treatment. In this trial, the dose determined to be the maximum tolerated dose will be the recommended phase 2 dose and will be utilized in the cohort expansion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegylated interferon alpha2a
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,776 Total Patients Enrolled
Sagar Patel, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiotherapy in the last 6 weeks.I can have a bone marrow biopsy as part of my pre-transplant evaluation.I can take care of myself but might not be able to do heavy physical work.I am not pregnant or I have been through menopause.I have a donor who is a perfect match for my transplant.I agree to use effective birth control during the study.I haven't had cancer treatment or experimental therapy recently.I have a history of mental health issues, autoimmune disease, or pancreatitis.I am eligible for intensive or less intensive bone marrow preparation treatment.I haven't had major surgery in the last 6 weeks or I've fully recovered from one.I have been diagnosed with myelofibrosis.I am receiving a stem cell transplant from blood.I haven't had another cancer diagnosis in the last 2 years, or it was treated successfully.I am 18 years old or older.My liver and kidney functions are within normal ranges.I am willing and able to sign the consent form for the trial.I do not have an active infection like HIV, tuberculosis, or hepatitis C.I have autoimmune hepatitis or severe liver disease.I understand the study details and can follow the study plan.I do not have active lung, stomach, or eye diseases.I am not taking any medications that are not allowed in the study.I do not have any severe ongoing illnesses that could interfere with the study.I have recovered from side effects of previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: All Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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