Status:
TERMINATED
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
Lead Sponsor:
City of Hope Medical Center
Conditions:
Iron Overload
Accelerated Phase Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload. PURPOSE: This pilot clinical trial studies...
Detailed Description
PRIMARY OBJECTIVES: I. To determine labile plasma iron (LPI) levels in iron overloaded patients after allogeneic Hematopoietic Stem Cell Transplantation (HSCT). II. To determine safety and tolerabil...
Eligibility Criteria
Inclusion
- Inclusion
- Patients must have undergone a matched related donor, matched unrelated donor or cord blood Hematopoietic Stem Cell Transplant (HSCT) over 6 months ago
- Patients currently on Desferal (desferrioxamine) therapy will require a one day wash out prior to the first dose of study drug
- Serum ferritin \>= 1500 ng/mL on two occasions two weeks apart at screening; samples must be obtained in the absence of concomitant infection
- Normal C-reactive protein level at screening
- Patients must be red cell transfusion independent for 2 months prior to enrollment
- Sexually active women must use an effective method of contraception, or must have undergone clinical documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
- Written informed consent by the patient
- Exclusion
- Chronic hepatic GVHD with serum total bilirubin over 2 mg/dL
- Known hypersensitivity to deferasirox
- Serum creatinine above the upper limit of normal
- AST or ALT \> 200 U/L during screening
- Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)
- History of HIV positive test result (ELISA or Western blot)
- History of drug or alcohol abuse within the 12 months prior to enrollment
- ECOG Performance Status \> 2
- Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
- Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
- Pregnancy (as documented in required screening laboratory test) or breast feeding
- Patients who received treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days or are planning to receive other investigational drugs while participating in the study
- Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
- History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01159067
Start Date
July 1 2010
End Date
August 9 2011
Last Update
June 18 2019
Active Locations (1)
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1
City of Hope
Duarte, California, United States, 91010