UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019313
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email norma@jichi.ac.jp

Sponsor
Institute department of hematology, division of internal medicine, Jichi Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.