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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 225 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 225 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 225 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anemia response, defined per IWG-MRT criteria (Phase 2a only)
Incidence of abnormal laboratory test results (Phase 1b only)
Incidence of clinically abnormal electrocardiograms (Phase 1b only)
+3 moreSecondary outcome measures
AUC-Area under the drug concentration time curve (Phase 1b and 2a)
Anemia response defined per IWG-MRT criteria (Phase 1b only)
CL/F-Apparent drug clearance (Phase 1b and 2a)
+14 moreTrial 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
413 Total Patients Enrolled
1 Trials studying Anemia
32 Patients Enrolled for Anemia
Will Savage, MD PhDStudy DirectorDisc Medicine
4 Previous Clinical Trials
371 Total Patients Enrolled
1 Trials studying Anemia
32 Patients Enrolled for Anemia
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for participants in this research project?
"Yes, this is accurate. The latest information on clinicaltrials.gov shows that the trial is still recruiting patients. This specific trial was first posted on June 6th, 2022 and was last updated October 20th, 2022."
Answered by AI
Do we have a broad understanding of this research in Canada?
"There are 8 total sites enrolling patients for this clinical trial, including Mayo Clinic Jacksonville in Jacksonville, Florida, University of Washington in Seattle, Washington, and Sargon Research - Pennsylvania Cancer Specialists and Research Center in Gettysburg, Pennsylvania."
Answered by AI
What is the total number of patients who will be participating in this research project?
"This study requires 56 patients that match the pre-specified inclusion criteria. The trial is taking place at various sites, such as Mayo Clinic Jacksonville in Jacksonville, Florida and University of Washington in Seattle, Washington."
Answered by AI
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