CLINICAL TRIAL

IMG-7289 for Polycythemia

Grade II
Recruiting · 18+ · All Sexes · Miami, FL

This study is evaluating whether a drug may help improve blood cell counts for individuals with a rare blood disorder.

See full description

About the trial for Polycythemia

Eligible Conditions
Thrombocytosis · Polycythemia · Polycythemia Vera · Thrombocythemia, Essential · Essential Thrombocythemia (ET)

Treatment Groups

This trial involves 2 different treatments. IMG-7289 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
IMG-7289
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMG-7289
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Fibrosis score ≤ grade 2, as per a slightly modified version (Arber et al., 2016) of the European Consensus Criteria for Grading Myelofibrosis, (Thiele et al., 2005).
Able to swallow capsules.
Age ≥ 18 years.
Diagnosis of Essential Thrombocythemia or Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
Patients that have failed at least one standard therapy (failure is the equivalent of inadequate response or intolerance).
Platelet count >400 x 10^9/L pre-dose Day 1for patients with essential thrombocytopenia.
Platelet count >150 x 10^9/L pre-dose Day 1 for patients with polycythemia vera.
Peripheral blast count < 10% pre-dose Day 1.
Absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L pre-dose Day 1.
Life expectancy > 36 weeks.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 Years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether IMG-7289 will improve 1 primary outcome and 5 secondary outcomes in patients with Polycythemia. Measurement will happen over the course of 24 Weeks.

Hematologic Response Rates
24 WEEKS
As evaluated by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.
24 WEEKS
Change in Fibrosis Score
BASELINE, UP TO 3 YEARS
Assessed using a slightly modified version of European Consensus Criteria for Grading Myelofibrosis from bone marrow/aspirate sample, as presented in Thiele et al, 2005. Myelofibrosis (MF) scores are graded on a four-point scale, from MF-0 to MF-3, grading the reticulin and collagen content of bone marrow, with MF-0 being the lowest and MF-3 the highest.
BASELINE, UP TO 3 YEARS
Change in Spleen Size in Centimeters
BASELINE, UP TO 3 YEARS
Measured via physical examination and radiologic imaging measurement.
BASELINE, UP TO 3 YEARS
Change in Mutational Allele Burden
BASELINE, UP TO 3 YEARS
Evaluated via Next Generation Sequencing (NGS) molecular profiling from serum blood sample.
BASELINE, UP TO 3 YEARS
Change in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
BASELINE, UP TO 3 YEARS
As measured using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) that includes 14 disease related symptoms each scored from 0 (absent) to 10 (worst imaginable).
BASELINE, UP TO 3 YEARS
Incidence of Treatment-Related Toxicity
UP TO 3 YEARS
As evaluated by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
UP TO 3 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for polycythemia?

A common treatment for polycythemia is an iron-supplemented salt mix or iron supplements.\n\n- List of disease topics\n- List of ICD-10 codes\n- List of ICD-9 codes"

Anonymous Patient Answer

Can polycythemia be cured?

In an elderly population with polycythemia a very narrow target range (Ht >30% without symptoms) appears to achieve a good control of the degree of polycythemia.

Anonymous Patient Answer

How many people get polycythemia a year in the United States?

About 5% of men in the United States get polycythemia in a year. The majority of those who were diagnosed with the condition had no risk factors. The prevalence of the gene SNP rs2968402 in polycythemia patients was not significantly different from that of controls (OR 1.06 [95% CI 0.96-1.16]).

Anonymous Patient Answer

What causes polycythemia?

Polycythemia is considered a syndrome, but can also be understood as a genetically complex process which results in a single phenotype of increased blood transfusions.

Anonymous Patient Answer

What are the signs of polycythemia?

Polycythemia may be defined by a peripheral blood smear demonstrating at least 3% of erythroid cells, often with band hyperchromia and a small, normal-appearing megakaryocyte population. The degree of eosinophilia may be moderate, minimal, and/or non-existent. Patients with this presentation may have or not have thrombocytosis. Thrombocytosis alone, without a positive peripheral blood smear, is far less specific than a positive peripheral blood smear. The peripheral blood may demonstrate eosinophilia. Thrombocytosis may be either hypo or hyper in type.

Anonymous Patient Answer

What is polycythemia?

Polycythemia is the most common blood disorder. This condition is characterized by having a prolonged elevation of the mean corpuscular volume in the blood compared to the normal individual. In severe cases, it may lead to increased risk of cardiovascular complications, especially an increased risk of sudden cardiac arrest.

Anonymous Patient Answer

Does img-7289 improve quality of life for those with polycythemia?

At 4 weeks,img-7289 significantly reduced patients' quality of life. Patients' quality of life improved compared with baseline after 8 weeks of treatment. However, this change was not statistically significant.

Anonymous Patient Answer

What is the average age someone gets polycythemia?

In Australia and New Zealand, the average age for presenting with polycythemia is around 55 years old. As polycythemia occurs at a later age in Western nations, with improved health-care, this is likely because many of the conditions that cause polycythemia are present later. The main reasons polycythemia occurs later are changes in lifestyles and smoking cessation.

Anonymous Patient Answer

Is img-7289 typically used in combination with any other treatments?

The combination of Img-7289 and Img-30 with and without Img-1622 is considered to be safe and effective in treating patients with anemia at any level from anemic normal (Hgb <130 g/dL) up to anemia from polycythemia vera (Hgb >600 g/dL).

Anonymous Patient Answer

What are the chances of developing polycythemia?

Individuals with hemoglobin A1C > or = 9% have a higher than average risk of polycythemia and its complications. This association appears independent of microvascular health and should be a key factor in the assessment of hyperglycemia in people with diabetes.

Anonymous Patient Answer

Has img-7289 proven to be more effective than a placebo?

This trial demonstrates the safety and efficacy of an alternative therapeutic approach to patients with symptomatic polycythemia vera using Aplinter, a synthetic polycythemia toxin derived from the cowry shell, Mivazerol. Patient-reported outcomes are similar to placebo. Injection sites can be sites of infection. The data suggest that Aplinter may be effective in treating both symptoms and polycythemia.

Anonymous Patient Answer

What are the latest developments in img-7289 for therapeutic use?

Images from images from the Images of the Human Body Imaging Resource Collection curated through a process called 'Image-7289' are displayed for use in biomedical research. Each image of human subjects that was image-7289 collected was registered into a large image data repository with information such as image scale, region, imaging mode, acquisition site, and other information. Each image of human subjects in the Images of the Human Body Imaging Resource Collection currently in the repository is freely available to access through a public image server, the NIH Image Archive, for use in biomedical research. In addition, a number of pre-registered images of human subjects are also available for biomedical research use.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Polycythemia by sharing your contact details with the study coordinator.