Health TrialsbyHealthPanel

Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow

ConditionsMyelofibrosisMyelofibrosis; Anemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age

Have a diagnosis of myelofibrosis (MF) according to the 2016 WHO criteria

Has a hemoglobin ≤ 10gm/dL at screening

Serum ferritin ≥ 100

Disqualifiers

Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3

Currently pregnant or planning on being pregnant within the study period.

Currently taking Momelotinib or Pacritinib (these agents are purported to reduce hepcidin).

Currently taking any of the contraindicated medications to Nelfinavir listed in section 13.2

Trial design

Design model

Single group

Treatments tested in this trial

  • Nelfinavir

    Drug

    Taken twice daily

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: NelfinavirExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hepcidin Levels

Comparison of Hepcidin Levels prior to and after Nelfinavir treatment

Time frame
30 days

Secondary outcomes

1

Change in Hemoglobin Levels

Comparison of hemoglobin levels to determine whether there is restoration of iron to the bone marrow.

Time frame
30 days
2

Change From Baseline in Serum Fibrosis Biomarker Concentrations

To evaluate if nelfinavir lowers fibrosis biomarkers in serum.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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