Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iro… (NCT01159067) | Clinical Trial Compass
TerminatedPhase 2
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
Stopped: Low enrollment
United States1 participantsStarted 2010-07
Plain-language 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 safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose deferasirox on labile plasma iron is also examined.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)