Clinical trial · Interventional
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload
NCT01273766CI-TRIAL-00034747completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (136)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| deferasirox | Drug | — | UNRESOLVED |
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: deferasirox
- Other: laboratory biomarker analysis
- Other: enzyme-linked immunosorbent assay
- type
- NO_INTERVENTION
- label
- control arm
- description
- blood tested on healthy patients
- type
- NO_INTERVENTION
- label
- correlative
- description
- treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 =\< 5X Upper Limit of Normal (ULN) * Total bilirubin =\< 1.5 * Creatinine =\< 2X age-appropriate Upper Limit of Normal (ULN) OR creatinine clearance \>= 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
References
Publications (0)
Data not yet available
No reference posted for this study.