NCT01159067 · REGISTRY CONDITION SEARCH

Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2019-06-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)

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outcome · POSTED

Number of Patients With LPI Below 0.5 Umol/L After Treatment

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outcome · POSTED

Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment

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outcome · POSTED

Correlation of LPI With Serum Ferritin

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
intervention Names
Drug: deferasirox
label
Arm I
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I
description
Given orally
name
deferasirox
other Names
Exjade
ICL670
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 1
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
time Frame
At baseline

secondary Outcomes

description
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.
measure
Number of Patients With LPI Below 0.5 Umol/L After Treatment
time Frame
Assessed through 6 months from the start of treatment
description
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.
measure
Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment
time Frame
Assessed through 6 months from the start of treatment
description
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.
measure
Correlation of LPI With Serum Ferritin
time Frame
Assessed through 6 months from the start of treatment

Full study description

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 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.
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 tolerability of low dose deferasirox in the post allogeneic HSCT setting. SECONDARY OBJECTIVES: I. To determine ability of deferasirox to suppress LPI in allogeneic HSCT patients with serum ferritin over 1500 ng/ml. II. To determine prevalence of elevated LPI in allogeneic HSCT recipients with serum ferritin over 1500 ng/ml. III. To determine ability of low dose deferasirox to lower serum ferritin during the treatment period. IV. To correlate LPI with serum ferritin in allogeneic HSCT recipients with serum ferritin over 1500 ng/ml. OUTLINE: Patients receive deferasirox at 10 mg/kg once daily for 6 months in the absence of unacceptable toxicity. Labile plasma iron will be measured at baseline and at weeks 4, 12, and 24. Side effects of deferasirox will be recorded.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice