Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy (Iron-RANC)

Temple University Health System (TUHS)

Status and phase: Enrolling; Phase 2

Conditions: Anemia

Treatments: Drug: Venofer

Study type: Interventional

Funder types: Other

Identifiers

NCT05800600

22-1053

HM-213 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients > 18 years
• Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, 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 HIPAA consent document

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, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would 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 due to 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Venofer treatment

Experimental group

Description:

Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion

Treatment:

Drug: Venofer