Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload
| Verified date | August 2018 |
| Source | Wake Forest University Health Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | December 2014 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only) | Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose) | Baseline, up to 6 months | |
| Secondary | Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics | Records will be assessed at baseline and prospectively while on study. | Baseline, up to 6 months | |
| Secondary | Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections | Records will be assessed at baseline and prospectively while on study. | Baseline, up to 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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