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

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ClinicalTrials.gov Identifier: NCT01159067
Recruitment Status : Terminated (Low enrollment)
First Posted : July 9, 2010
Results First Posted : May 29, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Iron Overload
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Atypical Chronic Myeloid Leukemia, BCR-ABL Negative
Blastic Phase Chronic Myelogenous Leukemia
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
de Novo Myelodysplastic Syndromes
Disseminated Neuroblastoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Poor Prognosis Metastatic Gestational Trophoblastic Tumor
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Neuroblastoma
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage II Ovarian Epithelial Cancer
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Malignant Testicular Germ Cell Tumor
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Ovarian Epithelial Cancer
Stage III Small Lymphocytic Lymphoma
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Breast Cancer
Stage IV Chronic Lymphocytic Leukemia
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Ovarian Epithelial Cancer
Stage IV Small Lymphocytic Lymphoma
Intervention Drug: deferasirox
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
Hide Description [Not Specified]
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Number of Patients With LPI Below 0.5 Umol/L After Treatment
Hide 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.
Time Frame Assessed through 6 months from the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No patient had elevated LPI level above 0.5umol/L at baseline.
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment
Hide 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.
Time Frame Assessed through 6 months from the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
4.Secondary Outcome
Title Correlation of LPI With Serum Ferritin
Hide 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.
Time Frame Assessed through 6 months from the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The enrolled patient's LPI level at baseline is below 0.5 umol/L and she had both LPI and Serum Ferritin levels measured at baseline only. Therefore, no sufficient data to estimate the correlation of LPI with Serum Ferritin.
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From Cycle 1 to Cycle 6
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Iron overload  1  1/1 (100.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  2
Platelets  1  1/1 (100.00%)  10
Cardiac disorders   
Hypotension  1  1/1 (100.00%)  1
Gastrointestinal disorders   
Anorexia  1  1/1 (100.00%)  1
Nausea  1  1/1 (100.00%)  6
Vomiting  1  1/1 (100.00%)  1
Hemorrhage, GU  1  1/1 (100.00%)  5
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/1 (100.00%)  1
Fever  1 [1]  1/1 (100.00%)  1
Rigors/chills  1  1/1 (100.00%)  1
Pain  1  1/1 (100.00%)  5
Infections and infestations   
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)  1 [2]  1/1 (100.00%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils  1  1/1 (100.00%)  1
Metabolism and nutrition disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/1 (100.00%)  6
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  1/1 (100.00%)  7
Albumin, serum-low (hypoalbuminemia)  1  1/1 (100.00%)  1
Alkaline phosphatase  1  1/1 (100.00%)  6
Creatinine  1  1/1 (100.00%)  4
Glucose, serum-high (hyperglycemia)  1  1/1 (100.00%)  1
Magnesium, serum-high (hypermagnesemia)  1  1/1 (100.00%)  3
Proteinuria  1  1/1 (100.00%)  2
Sodium, serum-low (hyponatremia)  1  1/1 (100.00%)  2
Uric acid, serum-high (hyperuricemia)  1  1/1 (100.00%)  3
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy)  1  1/1 (100.00%)  1
Nervous system disorders   
Mood alteration  1  1/1 (100.00%)  1
Neuropathy: sensory  1  1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory  1  1/1 (100.00%)  1
Cough  1  1/1 (100.00%)  2
Dyspnea (shortness of breath)  1  1/1 (100.00%)  1
Nasal cavity/paranasal sinus reactions  1  1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
Hypopigmentation  1  1/1 (100.00%)  6
Ulceration  1  1/1 (100.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
[2]
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Vinod Pullarkat
Organization: City of Hope National Medical Center
Phone: 626-256-4673 ext 82405
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01159067     History of Changes
Other Study ID Numbers: 09187
NCI-2010-01428
First Submitted: July 6, 2010
First Posted: July 9, 2010
Results First Submitted: May 2, 2019
Results First Posted: May 29, 2019
Last Update Posted: June 18, 2019