Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Last updated: March 10, 2025
Sponsor: Fox Chase Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Anemia

Treatment

Venofer

Clinical Study ID

NCT05800600
22-1053
HM-213
  • Ages > 18
  • All Genders

Study Summary

This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients > 18 years

  • Patients undergoing neoadjuvant chemotherapy, including radiation and/orimmunotherapy, with intent for curative surgical resection for breast, thoracic,gastrointestinal (GI) or genitourinary (GU) malignancies.

  • Anemia defined as Hgb <10.5 g/dL during chemotherapy.

  • Iron storage levels of ferritin <500 ng/mL and iron saturation <35%

  • Ability to understand and willingness to sign a written informed consent and HIPAAconsent document

Exclusion

Exclusion Criteria:

  • Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb < 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoingactive infection, symptomatic new/exacerbated congestive heart failure, unstableangina pectoris, cardiac arrhythmia, or psychiatric illness/social situations thatwould limit compliance with study requirements

  • Prior parenteral iron infusion in the past 4 weeks

  • The use of erythropoietin stimulating agents within 4 weeks unless chronic needs dueto CKD

  • Concurrent systemic infection at the time of enrollment.

  • Known hypersensitivity to Iron sucrose

  • Pregnant or breast feeding. Refer to section 4.4 for further detail.

  • Anemia from another established etiology (i.e MDS, Myeloma)

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Venofer
Phase: 2
Study Start date:
March 15, 2023
Estimated Completion Date:
February 01, 2027

Study Description

This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.

Connect with a study center

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

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