A Phase 2 interventional study of deferasirox and laboratory biomarker analysis in Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Supportive care
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.
PRIMARY OBJECTIVES: I. To determine the effects of the iron-chelating agent deferasirox on changes in: neutrophil function; macrophage function; lymphocyte function.
SECONDARY OBJECTIVES: I. To determine the effect of chelation on the incidence of bacterial, viral and fungal infections documented by clinical, microbiologically-proven versus radiologically-proven criteria. II. To determine the effect of iron chelation on mortality and morbidity with incidence of the following parameters: Need for hospitalization; Duration of hospitalization; Need for ventilatory support; Need for exchange transfusion/apheresis; Need for treatment with antifungals or antibiotics for documented infections.
OUTLINE: Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
246 studies on the registry are indexed under Leukemia, Biphenotypic, Acute; 56 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 185 interventional studies indexed under Leukemia, Biphenotypic, Acute.
Browse Leukemia, Biphenotypic, Acute studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
Drug: deferasirox · Other: laboratory biomarker analysis · Other: enzyme-linked immunosorbent assay
blood tested on healthy patients
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
Given orally
Also known as: Exjade, ICL670
Correlative studies
Correlative studies
Also known as: ELISA
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)
Time frame: Baseline, up to 6 months
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.
Time frame: Baseline, up to 6 months
Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections
Records will be assessed at baseline and prospectively while on study.
Time frame: Baseline, up to 6 months
| Milestone | Arm I | Control Arm | Correlative |
|---|---|---|---|
| Started | 4 | 7 | 5 |
| Completed | 4 | 7 | 5 |
| Not completed | 0 | 0 | 0 |
Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
| 10^9 Neutrophils per Liter | Arm I |
|---|---|
| Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only) | 7.8 ± 138.4 |
Records will be assessed at baseline and prospectively while on study.
| Participants | Arm I | Correlative |
|---|---|---|
| Baseline : Hospitalization | 2 | 5 |
| Baseline : Ventilator | 0 | 1 |
| Baseline : Transfusion | 0 | 0 |
| Baseline : Antibiotics | 0 | 5 |
| 1 Month : Hospitalization | 1 | 1 |
| 1 Month : Ventilator | 0 | 0 |
| 1 Month : Transfusion | 0 | 1 |
| 1 Month : Antibiotics | 1 | 1 |
| 2 Month : Hospitalization | 0 | 1 |
| 2 Month : Ventilator | 0 | 0 |
| 2 Month : Transfusion | 0 | 1 |
| 2 Month : Antibiotics | 0 | 1 |
| 3 Month : Hospitalization | 0 | 1 |
| 3 Month : Ventilator | 0 | 0 |
| 3 Month : Transfusion | 0 | 1 |
| 3 Month : Antibiotics | 0 | 0 |
| 4 Month : Hospitalization | 0 | 1 |
| 4 Month : Ventilator | 0 | 1 |
| 4 Month : Transfusion | 0 | 1 |
| 4 Month : Antibiotics | 1 | 1 |
| 5 Month : Hospitalization | 0 | 2 |
| 5 Month : Ventilator | 0 | 0 |
| 5 Month : Transfusion | 0 | 0 |
| 5 Month : Antibiotics | 0 | 1 |
| 6 Month : Hospitalization | 3 | 0 |
| 6 Month : Ventilator | 0 | 0 |
| 6 Month : Transfusion | 0 | 0 |
| 6 Month : Antibiotics | 1 | 0 |
Records will be assessed at baseline and prospectively while on study.
| Participants | Arm I | Correlative |
|---|---|---|
| Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections | 2 | 5 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 4/4 (100%) | 4/4 (100%) |
| Control Arm | — | — | — |
| Correlative | — | — | — |
| Event | Arm I | Control Arm | Correlative |
|---|---|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/4 | — | — |
| FatigueGeneral disorders | 2/4 | — | — |
| hyperglycemiaInvestigations | 2/4 | — | — |
| hyponatremiaInvestigations | 1/4 | — | — |
| hypokalemiaInvestigations | 1/4 | — | — |
| serum glutamic pyruvic transaminaseInvestigations | 1/4 | — | — |
| Thrombosis/thrombus/embolismVascular disorders | 1/4 | — | — |
| Heartburn/dyspepsiaGeneral disorders | 1/4 | — | — |
| ConfusionGeneral disorders | 1/4 | — | — |
| "Distension bloating, abdominal"General disorders | 1/4 | — | — |
| Event | Arm I | Control Arm | Correlative |
|---|---|---|---|
| Low HemoglobinInvestigations | 4/4 | — | — |
| hyperglycemiaInvestigations | 4/4 | — | — |
| hypocalcemiaInvestigations | 4/4 | — | — |
| hypoalbuminemiaInvestigations | 4/4 | — | — |
| low PlateletsInvestigations | 3/4 | — | — |
| Alkaline phosphataseInvestigations | 3/4 | — | — |
| hypomagnesemiaInvestigations | 3/4 | — | — |
| hyponatremiaInvestigations | 3/4 | — | — |
| Dry mouthGeneral disorders | 3/4 | — | — |
| Mucositis/stomatitis Oral cavityInfections and infestations | 3/4 | — | — |
| Age, Categorical(Participants) | Arm I | Control Arm | Correlative | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 7 | 4 | 14 |
| >=65 years | 1 | 0 | 1 | 2 |
| Age, Continuous(years) | Arm I | Control Arm | Correlative | Total |
|---|---|---|---|---|
| Mean | 53.1 ± 12.9 | 40.1 ± 7.0 | 55.0 ± 17.6 | 48.0 ± 14.5 |
| Sex: Female, Male(Participants) | Arm I | Control Arm | Correlative | Total |
|---|---|---|---|---|
| Female | 2 | 6 | 1 | 9 |
| Male | 2 | 1 | 4 | 7 |
| Region of Enrollment(participants) | Arm I | Control Arm | Correlative | Total |
|---|---|---|---|---|
| United States | 4 | 7 | 5 | 16 |
The record gives a start of Jan 2011, a primary completion of Mar 2012 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deferasirox
Leukemia, Biphenotypic, Acute →
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