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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011251
Receipt No. R000012992
Scientific Title Efficacy and safety of deferasirox after allogeneic stem cell transplantation: a multicenter prospective clinical study (KSGCT1302 / SCTICT)
Date of disclosure of the study information 2013/07/23
Last modified on 2018/01/24

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Basic information
Public title Efficacy and safety of deferasirox after allogeneic stem cell transplantation: a multicenter prospective clinical study
(KSGCT1302 / SCTICT)
Acronym KSGCT1302 / SCTICT
Scientific Title Efficacy and safety of deferasirox after allogeneic stem cell transplantation: a multicenter prospective clinical study
(KSGCT1302 / SCTICT)
Scientific Title:Acronym KSGCT1302 / SCTICT
Region
Japan

Condition
Condition Post-transplant iron overload
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of deferasirox for the patients with iron overload after allogeneic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Maximum tolerated dose of deferasirox
Key secondary outcomes (1)Medication course of deferasirox and maximum tolerated dose in a single case
(2)Ratio of decrease of serum ferritin, changes of iron-related or biochemical marker
(3)Development of adverse effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 According to the treatment algorithm, maximum tolerated dose of deferasirox is defined. Initial dose of deferasirox is 5 mg/kg. Only if the adverse effect is limited to grade 0 or 1 for 4 weeks, the identical dose of deferasirox is judged to be safe and the dose is shifted to the next step.
Developing grade 2 to 4 of adverse effects is judged to be failed.
No rules are present to stop the agent or decrease the dosage.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Age >=18 year old
(2)Over 6 month post transplantation
(3)Serum ferritin > 1000 ng/ml and total red blood cell transfusion >=20 units
(4)Hematological remission
(5)Organ dysfunction
Cr <1.0xULN, AST<3.0xULN and ALT<3.0xULN and T-bil<1.5xULN
(6)In tolerable for phlebotomy
(7)Chronic GVHD: none or mild
(8)Possibility of survival over 6 months
(9)PS: 0 or 1
(10)Informed consent
Key exclusion criteria (1)No hematological remission
(2)History of post-transplant iron chelating therapy
(3)Chronic GVHD: moderate or severe
(4)History of treatment for HBV or HCV hepatitis
(5)Active infection
(6)Uncontrollable complication
(7)Active double cancer
(8)Anafiraxis for deferasirox
(9)Other factors judged inappropriate by doctors
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichiro Okamoto
Organization Kanto Study Group for Cell Therapy
Division name Chairman
Zip code
Address Tokyo
TEL 03-6225-2040
Email ksgctdc@ksgct.net

Public contact
1st name of contact person
1st name
Middle name
Last name Takayoshi Tachibana
Organization Kanto Study Group for Cell Therapy
Division name Trial Office
Zip code
Address Kanagawa
TEL 045-787-2800
Homepage URL
Email tcbnt@yokohama-cu.ac.jp

Sponsor
Institute Kanto Study Group for Cell Therapy
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s12185-017-2396-9
Number of participants that the trial has enrolled
Results
Deferasirox for the treatment of iron overload after allogeneic hematopoietic cell transplantation: multicenter phase I study (KSGCT1302)
International Journal of Hematology
The arm of this study was to assess the safety and optimal dose of deferasirox for the treatment of iron overload after allogeneic hematopoietic cell transplantation (HCT). The primary endpoint was the maximum tolerated dose of deferasirox that was determined by the intrapatient dose escalation methods. A total of 16 patients with post-HCT iron overload were enrolled in the study. After excluding one case of early relapse, 15 remained evaluable. Their median age was 42 years (range 22-68). Median time from HCT to deferasirox administration was 9 months (range 6-84). Deferasirox was started at a dose of 5 mg/kg, and the dose was increased to 7.5 and 10 mg/kg every 4 weeks unless there were no grade => 2 of adverse events.
Achievement rates of planned medication were 80% in 5 mg/kg (12 of 15), 73% in 7.5 mg/kg (11 of 15), and 60% in 10 mg/kg (9 of 15), respectively. The reasons for discontinuation of the drug were grade 2 of adverse events (n = 4), late relapse (n = 1), and self-cessation (n = 1). None of the patients developed grade => 3 of adverse events or exacerbation of GVHD.
Among 11 evaluable cases, mean value of ferritin decreased from 1560 ng/ml pre-treatment to 1285 ng/ml post-treatment.
These data suggested that 10 mg/kg of deferasirox may be maximum tolerated dose when given after HCT. Our dose escalating method of deferasirox is useful to identify the optimal dosage of the drug in each patient.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 23 Day
Last modified on
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012992

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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