Phase 2 N=16 Supportive Care

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies

Acute Undifferentiated Leukemia · Adult Acute Lymphoblastic Leukemia in Remission · Adult Acute Myeloid Leukemia in Remission · Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q)

Bottom Line

View on ClinicalTrials.gov: NCT01273766 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Nov 2013

Primary outcome: Primary: Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only) — 7.8 10^9 Neutrophils per Liter

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: deferasirox (Drug); laboratory biomarker analysis (Other); enzyme-linked immunosorbent assay (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)	7.8	—
SECONDARY Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics	2; 5; 0; 1; 0; 0	—
SECONDARY Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections	2; 5	—

Summary

RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.

Eligibility Criteria

Inclusion Criteria

Patients must have a pathology confirmed diagnosis of one of the following: myelodysplastic syndrome (MDS); acute leukemia; multiple myeloma; myelofibrosis; lymphoma; chronic anemia; sickle cell anemia
Iron score >= 2
Absolute Neutrophil Count (ANC) >= 1,000
Platelets >= 50,000
Albumin >= 2 g/dL
Alkaline phosphatase = = 40 ml/min
Serum Glutamic Oxaloacetic Transaminase (SGOT) [AST] and Serum Glutamic Pyruvic Transaminase (SGPT) [ALT] =< 5X Upper Limit of Normal (ULN)
Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients with active disease undergoing chemotherapy treatment
Patient who have been treated with rituximab or immunomodulating drugs =< 1 month prior to enrollment
HIV-positive patients
Hepatitis-C positive patients
Women who are pregnant or breastfeeding
Patients on hemodialysis/patients with renal failure
Patients with sepsis or acute illness
Known hypersensitivity to deferasirox
Patients with moderate or severe hearing loss as defined by audiogram

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01273766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.