This is a Phase 2 open label study of an orally administered LSD1 inhibitor, bomedemstat (IMG-7289), in patients with polycythemia vera. This study investigates the following: – The safety and tolerability of bomedemstat – The pharmacodynamic effect of bomedemstat
»Participating in This Clinical Trial:
CriteriaDiagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms – Bone marrow fibrosis score of Grade 0 or Grade 1 – Patients that have failed at least one standard cytoreductive therapy to lower hematocrit – Platelet count ≥250 x 10ˆ9/L – Absolute neutrophil count (ANC) ≥1.5 x 10ˆ9/L – Life expectancy >36 weeks. – Must have discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation. Exclusion Criteria:Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater – Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1). – Uncontrolled active infection. – Current use of prohibited medications – Known HIV infection or active Hepatitis B or Hepatitis C virus infection – Evidence of increased risk of bleeding, including known bleeding disorders – Other hematologic/biochemistry requirements, as per protocol – Pregnant or lactating femalesGender Eligibility: AllMinimum Age: 18 YearsMaximum Age: N/A »
Initially Bom was targeted for PLT. But they are seeing HCT benefits, so make sense to try on PV. One member, Miriammusic, dropped out of the ET trial for tolerance troubles.
Yes, I think it is a great drug if you can manage the effects. Others on it are doing well, I wish I could have said the same. It did improve my counts for a while. I think we will be hearing a lot more about it.
Miriammusic, can you say what your effects were? I was taken off Besremi for liver problems and my local doctor doesn't have any other suggestions aside from HU for me. I see there is a Bom trial in Skokie, Illinois.
Yes, diagnosis quickly moved on to PV. But now that I’m off besremi I noticed that it’s my platelets that are rising again not so much HCT. Medicare IS disputing the besremi I took but only because clinic continued to inject while dose was determined.
At 8 weeks after pausing Besremi due to high liver enzymes, my enzymes are coming back into line. One is normal, the other a tiny bit above normal. I don't yet know if I will go back to Besremi, but was so happy the liver was recovering. I took liver detox Traditional Chinese Medicine, and when that ran out, had some milk thistle tea I made from the seeds. I've also been religious about liver cleansing while doing Qi Gong. I did have itchy bumps raised on my arms and back during this liver mending time, but not sure if that was related to the liver cleansing itself, or my gardening efforts. I will talk to the Mayo doc I saw by video in December about Besremi, Rux and so forth to see where I'm going from here. I also may approach clinic for a change of docs locally.
By the way, my platelets during the Besremi two month pause rose from a low of 400 -something to 600 - something, but my dear HCT level is holding strong. Hard to get all that water down, but I think that is helping me. Just adding my stats for group info!
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A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia
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