Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Deferasirox Treatment and Labile Plasma Iron in Iron Overloaded Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
| Verified date | November 2017 |
| Source | City of Hope Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | August 9, 2011 |
| Est. primary completion date | August 9, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | City of Hope | Duarte | California |
| Lead Sponsor | Collaborator |
|---|---|
| City of Hope Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L) | At baseline | ||
| Secondary | Number of Patients With LPI Below 0.5 Umol/L After Treatment | In patients with LPI values above threshold 0.5umol/L at baseline, number of patients had LPI suppressed below this value after treatment. Measurement of LPI is done on plasma specimens. | Assessed through 6 months from the start of treatment | |
| Secondary | Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment | Number of patients, whose Serum Ferritin levels are lower than 1500 ng/mL at two consecutive study visits. Serum Ferritin levels are measured at screening (baseline), week 4, 8, 12, 16, 20, 24 and end of study. | Assessed through 6 months from the start of treatment | |
| Secondary | Correlation of LPI With Serum Ferritin | Both LPI and Serum Ferritin levels are measured at screening (baseline), week 4, 12, 24 and end of study. The correlation between the levels of LPI and Serum Ferritin at screening, week 4, 12, 24 and end of study will be examined and plotted. | Assessed through 6 months from the start of treatment |
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