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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4 (intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as confirmed in the most recent local bone marrow biopsy report, according to World Health Organization (WHO) 2016 criteria
Must not have
Known allergic reactions, anti-drug antibody formation, inadequately controlled heart disease, active Hepatitis B or C, or HIV with detectable viral load
Treatment History exclusions including recent iron chelation therapy and change in anticoagulant therapy regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how safe and tolerable a new drug is, as well as how it affects anemia in people with myelofibrosis.
Who is the study for?
Adults over 18 with myelofibrosis and anemia can join this trial. They should have a certain level of disease severity, be able to perform daily activities, and have kidneys that work well enough. Participants need to stop some treatments before joining and meet specific blood count criteria. People who've had recent major surgery or other cancers (with exceptions), active infections, or severe heart problems cannot join.
What is being tested?
The study is testing DISC-0974's safety and how it affects the body in patients with myelofibrosis-related anemia. It's an early-stage trial where everyone gets the drug; there are no comparison groups.
What are the potential side effects?
Since DISC-0974 is still being studied, potential side effects aren't fully known yet but may include typical drug reactions like nausea, headaches, allergic responses or more specific effects related to its action on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
My bone marrow biopsy shows I have a high-risk form of myelofibrosis.
Select...
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 do not have severe allergies, heart issues, active Hepatitis B or C, or uncontrolled HIV.
Select...
I haven't had recent iron removal treatment or changed my blood thinner regimen.
Select...
I do not have any untreated fungal, bacterial, or viral infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2a: ExpansionExperimental Treatment1 Intervention
In the Phase 2a (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.
Group II: Phase 1b: Dose EscalationExperimental Treatment1 Intervention
In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DISC-0974
2021
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Disc Medicine, IncLead Sponsor
5 Previous Clinical Trials
431 Total Patients Enrolled
Will Savage, MD PhDStudy DirectorDisc Medicine
4 Previous Clinical Trials
389 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.My bone marrow biopsy shows I have a high-risk form of myelofibrosis.I am not expected to have a stem cell transplant within the next 8 months.I am 18 years old or older.I have not taken certain medications for at least 28 days.I do not have severe allergies, heart issues, active Hepatitis B or C, or uncontrolled HIV.I haven't had recent iron removal treatment or changed my blood thinner regimen.I haven't had any other cancers in the last 3 years, with some exceptions.I have not had a stroke or blood clot in the past 6 months.I am on a stable dose of JAK inhibitor, hydroxyurea, or momelotinib.I do not have any untreated fungal, bacterial, or viral infections.I don't have genetic blood disorders, recent major surgeries, or specific anemia types.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Escalation
- Group 2: Phase 2a: Expansion
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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