Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
Status and phase
Completed
Phase 2
Conditions
Stage III Mantle Cell Lymphoma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage IV Marginal Zone Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Stage II Adult T-cell Leukemia/Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Stage III Grade 3 Follicular Lymphoma
Small Intestine Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Stage I Multiple Myeloma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Stage III Adult Diffuse Large Cell Lymphoma
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Multiple Myeloma
Stage III Marginal Zone Lymphoma
Hepatosplenic T-cell Lymphoma
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Untreated Adult Acute Myeloid Leukemia
Stage I Grade 2 Follicular Lymphoma
Refractory Multiple Myeloma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage I Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Acute Lymphoblastic Leukemia
Stage III Mycosis Fungoides/Sezary Syndrome
Recurrent Adult Lymphoblastic Lymphoma
Stage III Small Lymphocytic Lymphoma
Stage I Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Noncutaneous Extranodal Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage I Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Acute Myeloid Leukemia
Acute Undifferentiated Leukemia
Peripheral T-cell Lymphoma
Stage II Multiple Myeloma
Stage IV Small Lymphocytic Lymphoma
Stage I Marginal Zone Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Splenic Marginal Zone Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Adult Acute Myeloid Leukemia in Remission
Stage I Small Lymphocytic Lymphoma
Contiguous Stage II Adult Burkitt Lymphoma
Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Stage IV Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Adult Langerhans Cell Histiocytosis
Refractory Anemia
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Small Lymphocytic Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia
Stage I Adult Burkitt Lymphoma
Stage III Adult Hodgkin Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Secondary Myelofibrosis
Contiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Noncontiguous Stage II Adult Burkitt Lymphoma
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage I Mantle Cell Lymphoma
Waldenstrom Macroglobulinemia
Recurrent Adult Hodgkin Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Previously Treated Myelodysplastic Syndromes
Anaplastic Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Testicular Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
Stage II Adult Hodgkin Lymphoma
Intraocular Lymphoma
Adult Acute Myeloid Leukemia With Del(5q)
Myelodysplastic Syndrome With Isolated Del(5q)
de Novo Myelodysplastic Syndromes
Contiguous Stage II Small Lymphocytic Lymphoma
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Adult Acute Lymphoblastic Leukemia in Remission
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Myeloid/NK-cell Acute Leukemia
Contiguous Stage II Grade 2 Follicular Lymphoma
Stage I Adult T-cell Leukemia/Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Mast Cell Leukemia
Primary Myelofibrosis
Secondary Acute Myeloid Leukemia
Recurrent Adult T-cell Leukemia/Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Treatments
Other: enzyme-linked immunosorbent assay
Drug: deferasirox
Other: laboratory biomarker analysis
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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.
Full description
PRIMARY OBJECTIVES: I. To determine the effects of the iron-chelating agent deferasirox on changes in: neutrophil function; macrophage function; lymphocyte function.
SECONDARY OBJECTIVES: I. To determine the effect of chelation on the incidence of bacterial, viral and fungal infections documented by clinical, microbiologically-proven versus radiologically-proven criteria. II. To determine the effect of iron chelation on mortality and morbidity with incidence of the following parameters: Need for hospitalization; Duration of hospitalization; Need for ventilatory support; Need for exchange transfusion/apheresis; Need for treatment with antifungals or antibiotics for documented infections.
OUTLINE: 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.
Enrollment
16 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Supportive Care
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
16 participants in 3 patient groups
Arm I
Experimental group
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.
Treatment:
Other: laboratory biomarker analysis
Drug: deferasirox
Other: enzyme-linked immunosorbent assay
control arm
No Intervention group
Description:
blood tested on healthy patients
correlative
No Intervention group
Description:
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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