UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019313 |
|---|---|
| Receipt number | R000022274 |
| Scientific Title | Phase II study for patient with Philadelphia chromosome positive acute lymphoblastic leukemia to determin the role of Dasatinb combined chemotherapy and allogeneic stem cell transplantation (PHII PHD) |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2016/11/02 11:07:50 |
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Basic information
Public title
Phase II study for patient with Philadelphia chromosome positive acute lymphoblastic leukemia
to determin the role of Dasatinb combined chemotherapy and allogeneic stem cell transplantation (PHII PHD)
Acronym
Phase II study for patient with Ph+ALL to determin the role of Dasatinb combined chemotherapy and allogeneic SCT (PH-II PH-D)
Scientific Title
Phase II study for patient with Philadelphia chromosome positive acute lymphoblastic leukemia
to determin the role of Dasatinb combined chemotherapy and allogeneic stem cell transplantation (PHII PHD)
Scientific Title:Acronym
Phase II study for patient with Ph+ALL to determin the role of Dasatinb combined chemotherapy and allogeneic SCT (PH-II PH-D)
Region
| Japan |
Condition
Condition
newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this study is to determine the clinical efficacy and safety of dasatinib combined chemotherapy and followed by allogeneic stem cell transplantation on newly diagnosed Ph positive ALL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
the rate of complete remission after induction chemotherapy
Key secondary outcomes
2 years disease free survival, event free survival, and over all survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. PSL pre phase therapy:
PSL 60mg/m2x7days
2. Induction chemotherapy:
Dasatinib 140mg/body x 6 weeks + PSL 60mg/m2x2 weeks. At week 3 and 6, intrathecal MTX 15mg+Ara-C 40mg+DEX 4mg.
3. Consolidation 1,3,5,7 course:
Dasatinib 100mg/bodyx2weeks+ HyperCVAD
CPA 300mg/m2x2 times/day 3hr div (d1-d3)+
VCR 1.4mg/m2 (max 2mg) 30min div (d4, d11)+
DXR 50mg/m2 30min div (d4)+
DEX 33mg/body 30min div or 40mg PO (d1-4, d11-14)
intrathecal MTX 15mg+Ara-C 40mg+DEX 4mg(d1)
4. Consolidation 2,4,6, 8 course:
Dasatinib100mg/bodyx2weeks+
MTX 1g/m2 24hr continuous infusion d1+
Ara-C 2g/m2x2 times 3hr div d2-3+
mPSL 50mg/bodyx2 times iv d1-3
leucovorin 15mg iv d2-3
5. maintenance Dasatinib:
Dasatinib 100-140mg/body from the last day of consolidation for 2 years.
6. allogeneic stem cell transplantation:
For patient 65 years old or younger, if appropriate donor is available, allograft is recommended as possible as 1st remission.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Philadelphia chromosome positive, acute lymphoblastic leukemia, or blastic phase chronic myelogenous leukemia who are not comfirmed chronic phase, or mixed phenotype acute leukemia.
2.BCR/ABL chimera mRNA positive if patients are Ph negative.
3.Aged older than 18 years and under 65 years
4.Previously untreated except PSL in the prephase therapy
5.ECOG performance status of 0, 1, 2, 3 except 4
6.Patients must have normal cardiac, heaptic, renal, respiratory functions to tolerate dasatinib.
(1)within normal range of ECG, ejection fruction
(2)serum bililubin level of <2.0mg/dl
(3)serum createnin level of <2.0mg/dl
(4)saturation pulse O2 level over 94% under room air condition
7.Voluntary written informed consent must be given before enrollment. If patient are younger than 20, parental agreement must be included.
Key exclusion criteria
1.Active another malignancy
2.Uncontrolled past disease or complication
3.Previously treated with tyrosine kinase inhibitor or cytotoxic chemotherapy.
4.HIV antibody positive patients
5.HBs-Antigen positive patients
6.Sever psychiatric illness
7.Another patients whose investigator decided inappropriate for entry into this study.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
Jichi Medical University
Division name
Department of hematology, division of internal medicine,
Zip code
Address
yakusiji 3311-1, simotsuke city, tochigi, Japan
TEL
0285-58-7353
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iekuni Oh |
Organization
Jichi Medical University
Division name
Department of hematology, division of internal medicine,
Zip code
Address
yakusiji 3311-1, simotsuke city, tochigi, Japan
TEL
0285-58-7353
Homepage URL
norma@jichi.ac.jp
Sponsor or person
Institute
department of hematology, division of internal medicine, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of hematology, division of internal medicine, Jichi Medical University
Organization
Division
Category of Funding Organization
Other
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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022274
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