Portomar Device for Blood Cancers

Overseen By Bob Rioux

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aperture Medical Technology, LLC

Must not be taking: Anticoagulants

Disqualifiers: Uncontrolled diabetes, Heart failure, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a self-controlled, prospective trial. The objective of this trial is to evaluate the efficacy and safety of the Portomar(TM) device for bone marrow biopsy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are unable to stop taking anticoagulation medications for the procedure.

How is the Portomar Device treatment different from other treatments for blood cancers?

The Portomar Device is unique because it likely involves a novel mechanism of action or administration method, potentially related to therapeutic apheresis, which is a process that removes certain components from the blood. This approach is different from traditional drug therapies and may offer a new way to manage blood cancers. ^{1 2 3 4 5}

Research Team

Rahul Sheth

Principal Investigator

MD Anderson

Eligibility Criteria

This trial is for adults over 21 with certain blood cancers who need multiple bone marrow biopsies. They should be relatively active (ECOG ≤ 2), not pregnant, and have decent blood, kidney, and liver function. Participants must understand the study and agree to follow its rules.

Inclusion Criteria

I am 21 or older, not pregnant, and can care for myself.

I have a bone marrow disorder and will need several bone marrow tests.

I understand the study details and agree to participate willingly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo conventional bone marrow biopsy and bone marrow biopsy with the Portomar(TM) device

1 month

Day of bone marrow biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Portomar(TM) Device

Trial Overview The study is testing the Portomar(TM) device's effectiveness and safety in performing bone marrow biopsies compared to traditional methods. It's a self-controlled trial where patients serve as their own comparison group.

Participant Groups

Group I: Portomar(TM) Device Experimental Treatment 1 Intervention

Portomar(TM) Device for bone marrow biopsy Subjects are self-controlled with one side having conventional biopsy and the other having the Portomar(TM) biopsy.

Who Is Running the Clinical Trial?

Aperture Medical Technology, LLC

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

Therapeutic apheresis, which involves separating and removing certain components from the blood, has evolved significantly since its early development in the 1930s, particularly with the introduction of automated cell separators that improved its use in clinical settings.

Current guidelines from the American Society for Apheresis help hematologists make evidence-based decisions regarding the use of therapeutic apheresis for various hematological disorders, including modalities like plasma exchange and leukocytapheresis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for therapeutic apheresis in hematological disorders. Szczepiorkowski, ZM.[2021]

Recent advances in thrombotic risk stratification for polycythemia vera (PV) and essential thrombocythemia (ET) have been enhanced by international collaborations and technologies like next-generation sequencing, improving patient care significantly.

Ruxolitinib and interferon have shown excellent efficacy and safety in clinical trials, confirming their effectiveness as both first- and second-line treatments, while early trials of novel agents indicate promising results in managing symptoms and blood counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Risk Stratification and Treatment of Polycythemia Vera and Essential Thrombocythemia. Krecak, I., Lucijanic, M., Verstovsek, S.[2022]

Chronic myeloproliferative neoplasms (MPN) are linked to vascular complications, with clonal hematopoiesis contributing to increased risks of cardiovascular events and solid cancers due to chronic inflammation.

The study suggests that targeting clonal hematopoiesis and inflammation could lead to new antithrombotic therapies, potentially benefiting both MPN patients and the general population, especially the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clonal Hematopoiesis in Myeloproliferative Neoplasms Confers a Predisposition to both Thrombosis and Cancer. Barbui, T., Gavazzi, A., Sciatti, E., et al.[2023]

Polycythemia vera is primarily managed with aspirin and methods to reduce hematocrit, such as venesection or cytoreductive therapy, with hydroxyurea being the first-line treatment for high-risk patients despite its potential toxicities and resistance issues.

The review will evaluate alternative treatments like interferon and ruxolitinib for patients who are resistant to or cannot tolerate hydroxyurea, emphasizing the need for therapies that do not increase the risk of progression to acute leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of hydroxyurea resistant or intolerant polycythemia vera. Raman, I., Pasricha, SR., Prince, HM., et al.[2021]

Cytoreductive treatments, including phlebotomy and low-dose aspirin, have significantly reduced thrombotic complications in patients with polycythemia vera, leading to improved survival rates.

There is a concern that some myelosuppressive drugs may accelerate the progression of polycythemia vera to acute myeloid leukemia, highlighting the need for careful management to balance reducing thrombotic risks while preventing disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based management of polycythemia vera. Barbui, T., Finazzi, G.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Indications for therapeutic apheresis in hematological disorders. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Advances in Risk Stratification and Treatment of Polycythemia Vera and Essential Thrombocythemia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clonal Hematopoiesis in Myeloproliferative Neoplasms Confers a Predisposition to both Thrombosis and Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Management of hydroxyurea resistant or intolerant polycythemia vera. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence-based management of polycythemia vera. [2013]