UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011251 |
|---|---|
| Receipt number | 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 | 2023/06/08 19:57:26 |
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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
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
ksgctdc@ksgct.net
Public contact
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
tcbnt@yokohama-cu.ac.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
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
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012992
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| Registered date | File name |
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