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Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Primary Purpose

Myelodysplastic Syndrome, Iron Overload

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Deferasirox
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring ICL670, Deferasirox, Iron chelation, Chelator, Desferal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients with low or intermediate (INT-1) risk MDS Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO). Age greater than or equal to 18 years Availability of transfusion records for the 12 weeks prior to registration A lifetime minimum of 30 previous packed red blood cell transfusions Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration Serum Ferritin: For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year. Serum ferritin ≥ 1000 ng/mL at screening via the central lab. Life expectancy ≥ 6 months Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months) Able to provide written informed consent Exclusion Criteria: Serum creatinine above the upper limit of normal Alanine aminotransferase (ALT) > 500 U/L during screening Clinical or laboratory evidence of active Hepatitis B or C Urinary protein/creatinine ratio > 0.5 mg/mg History of HIV positive test result (ELISA or Western blot) Eastern Cooperative Oncology Group (ECOG) Performance Status > 2 Patients with uncontrolled systemic hypertension Unstable cardiac disease not controlled by standard medical therapy 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 or breast feeding Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days 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

Sites / Locations

  • Univ of Alabama Birmingham
  • Mayo Clinic
  • Bay Area Cancer Research Group
  • City of Hope National Medical Center
  • Cedars-Sinai Medical Center, UCLA School of Medicine
  • UCLA Medical Center
  • UCSF
  • UCSF
  • Rocky Mountain Cancer Centers
  • Mayo Clinic
  • Emory University School of Medicine/Winship Cancer Institute
  • Straub Clinic and Hospital
  • Novartis Investigative Site
  • University of Chicago Hospital
  • University of Kansas Medical Center
  • University of Kentucky College of Medicine, Markey Cancer Center
  • Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital
  • St. Agnes HealthCare
  • Rush Cancer Institute Univ. of Massachussets Medical Center
  • Novartis Investigative Site
  • Mayo Clinic
  • The Center for Cancer Care & Research (TCCCR)
  • Oncology Hematology West, PC
  • Dartmouth Hitchcock Medical Center
  • The Cancer Center at Hackensack University
  • NMOHC
  • Roswell Park Cancer Center
  • Rochester General Hospital/Lipson Cancer and Blood Center
  • Cancer Care of WNC
  • Wake Forest UniversitComprehensive Cancer Center
  • The Cleveland Clinic Foundation
  • The Ohio State University
  • Novartis Investigative Site
  • Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center
  • Western Pennsylvania Hospital Cancer Institute
  • The West Cancer Clinic
  • Novartis Investigative site
  • Baylor/The Methodist Hospital
  • Utah Cancer Specialists
  • Arlington Fairfax Hematology Oncology PC
  • Novartis Investigative Site
  • Medical College of Wisconsin
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICL670

Arm Description

Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS

Outcomes

Primary Outcome Measures

Number of Participants Reporting Adverse Events
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.

Secondary Outcome Measures

Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53
Change in levels of serum ferritin from baseline to 3, 6, 9 and 12 months (Weeks 13, 25, 37 and 53).
Change in Labile Plasma Iron (LPI)
LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The blood sample for LPI determinations was collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. LPI was calculated as 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe
Directly Chelatable Iron (DCI)
The blood sample for DCI determinations were collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49.
Total Iron Levels
Levels of non-transferrin bound iron (NTBI) and serum iron from baseline to 3,6,9 and 12 months (Weeks 13, 25, 37 and 49) were assessed.
Serum Transferrin Levels
Serum transferrin from baseline to 3, 6, 9 and 12 months of treatment (Visit Weeks 13, 25, 37 and 49) were assessed.
Transferrin Saturation
Levels of transferrin saturation from baseline to 3, 6, 9 and 12 months.
Transfusion Requirements
Number of participants receiving transfusions, the summarized during the study.
Frequency of Hematologic Improvement During the Study
Hematologic responses defined by International Working Group response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks defined as: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets: absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence.
Trough Plasma Deferasirox Concentration
The Pharmacokinetic (PK) parameters were assessed at Week 13, 25, 37 and 49 using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) method.
Treatment Compliance to Deferasirox
Treatment compliance was assessed using records of study medication used, dosages administered, and intervals between visits during the study. Drug accountability was noted by the field monitor during site visits and at the completion of the trial. Participants were asked to return all unused medication at monthly visits.
The Prevalence of Hereditary Hemochromatosis Gene (HFE) Gene Mutations
HFE (hemochromatosis) gene mutations in the Myelodysplastic Syndrome (MDS) population, the trial included testing for the C282Y, H63D and S65C HFE gene mutations. One blood sample was collected at Baseline (Week 1), or, if that visit was missing, the sample was taken at Week 13 (Month 3). Only one blood sample was to be taken from each participant.

Full Information

First Posted
May 4, 2005
Last Updated
July 21, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00110266
Brief Title
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Official Title
An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2005 (Actual)
Primary Completion Date
March 28, 2008 (Actual)
Study Completion Date
March 28, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
Detailed Description
Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome, Iron Overload
Keywords
ICL670, Deferasirox, Iron chelation, Chelator, Desferal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICL670
Arm Type
Experimental
Arm Description
Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS
Intervention Type
Drug
Intervention Name(s)
Deferasirox
Other Intervention Name(s)
ICL670A, chelator, desferal, iron chelation
Intervention Description
20 mg/kg/day over one year in patients with MDS
Primary Outcome Measure Information:
Title
Number of Participants Reporting Adverse Events
Description
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
Time Frame
up to 53 Weeks
Secondary Outcome Measure Information:
Title
Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53
Description
Change in levels of serum ferritin from baseline to 3, 6, 9 and 12 months (Weeks 13, 25, 37 and 53).
Time Frame
From Baseline to Weeks 13, 25, 37 and 53
Title
Change in Labile Plasma Iron (LPI)
Description
LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The blood sample for LPI determinations was collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. LPI was calculated as 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe
Time Frame
From Baseline to Weeks 13, 25, 37 and 49
Title
Directly Chelatable Iron (DCI)
Description
The blood sample for DCI determinations were collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49.
Time Frame
From Baseline to Weeks 13, 25, 37 and 49
Title
Total Iron Levels
Description
Levels of non-transferrin bound iron (NTBI) and serum iron from baseline to 3,6,9 and 12 months (Weeks 13, 25, 37 and 49) were assessed.
Time Frame
From Baseline to Weeks 13, 25, 37, 49 and 53
Title
Serum Transferrin Levels
Description
Serum transferrin from baseline to 3, 6, 9 and 12 months of treatment (Visit Weeks 13, 25, 37 and 49) were assessed.
Time Frame
From Baseline to Weeks 13, 25, 37, 49 and 53
Title
Transferrin Saturation
Description
Levels of transferrin saturation from baseline to 3, 6, 9 and 12 months.
Time Frame
From Baseline to Weeks 13, 25, 37, 49 and 53
Title
Transfusion Requirements
Description
Number of participants receiving transfusions, the summarized during the study.
Time Frame
up to 1 year
Title
Frequency of Hematologic Improvement During the Study
Description
Hematologic responses defined by International Working Group response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks defined as: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets: absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence.
Time Frame
up to 1 year
Title
Trough Plasma Deferasirox Concentration
Description
The Pharmacokinetic (PK) parameters were assessed at Week 13, 25, 37 and 49 using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) method.
Time Frame
At Week 13, 25, 37 and 49
Title
Treatment Compliance to Deferasirox
Description
Treatment compliance was assessed using records of study medication used, dosages administered, and intervals between visits during the study. Drug accountability was noted by the field monitor during site visits and at the completion of the trial. Participants were asked to return all unused medication at monthly visits.
Time Frame
up to 1 year
Title
The Prevalence of Hereditary Hemochromatosis Gene (HFE) Gene Mutations
Description
HFE (hemochromatosis) gene mutations in the Myelodysplastic Syndrome (MDS) population, the trial included testing for the C282Y, H63D and S65C HFE gene mutations. One blood sample was collected at Baseline (Week 1), or, if that visit was missing, the sample was taken at Week 13 (Month 3). Only one blood sample was to be taken from each participant.
Time Frame
up to Week 13 (Month 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients with low or intermediate (INT-1) risk MDS Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO). Age greater than or equal to 18 years Availability of transfusion records for the 12 weeks prior to registration A lifetime minimum of 30 previous packed red blood cell transfusions Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration Serum Ferritin: For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year. Serum ferritin ≥ 1000 ng/mL at screening via the central lab. Life expectancy ≥ 6 months Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months) Able to provide written informed consent Exclusion Criteria: Serum creatinine above the upper limit of normal Alanine aminotransferase (ALT) > 500 U/L during screening Clinical or laboratory evidence of active Hepatitis B or C Urinary protein/creatinine ratio > 0.5 mg/mg History of HIV positive test result (ELISA or Western blot) Eastern Cooperative Oncology Group (ECOG) Performance Status > 2 Patients with uncontrolled systemic hypertension Unstable cardiac disease not controlled by standard medical therapy 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 or breast feeding Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Univ of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Cedars-Sinai Medical Center, UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1678
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0324
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Emory University School of Medicine/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky College of Medicine, Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
St. Agnes HealthCare
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Rush Cancer Institute Univ. of Massachussets Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Novartis Investigative Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Center for Cancer Care & Research (TCCCR)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Oncology Hematology West, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124-2346
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
The Cancer Center at Hackensack University
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NMOHC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Rochester General Hospital/Lipson Cancer and Blood Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Cancer Care of WNC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Wake Forest UniversitComprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Western Pennsylvania Hospital Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Novartis Investigative site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor/The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Arlington Fairfax Hematology Oncology PC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Novartis Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5g 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22547607
Citation
List AF, Baer MR, Steensma DP, Raza A, Esposito J, Martinez-Lopez N, Paley C, Feigert J, Besa E. Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome. J Clin Oncol. 2012 Jun 10;30(17):2134-9. doi: 10.1200/JCO.2010.34.1222. Epub 2012 Apr 30.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2782
Description
Results for CICL670AUS03 from the Novartis Clinical Trials website
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=22547607
Description
Publication (Embasse # 2012421150)

Learn more about this trial

Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

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