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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025028
Receipt No. R000028790
Scientific Title An Analysis of Efficacy of Maintenance Dasatinib for Ph+ALL Patients after Allogeneic Hematopoietic Stem Cell Transplantation: Prospective Phase II trial
Date of disclosure of the study information 2016/11/28
Last modified on 2019/03/11

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Basic information
Public title An Analysis of Efficacy of Maintenance Dasatinib for Ph+ALL Patients after Allogeneic Hematopoietic Stem Cell Transplantation: Prospective Phase II trial
Acronym DASALL II
Scientific Title An Analysis of Efficacy of Maintenance Dasatinib for Ph+ALL Patients after Allogeneic Hematopoietic Stem Cell Transplantation: Prospective Phase II trial
Scientific Title:Acronym DASALL II
Region
Japan

Condition
Condition Ph+ Acute Lymphoblastic Leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of dasatinib administration in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) after hematopoietic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Survival rate at 2 years after transplantation
2. Recurrence rate by 2 years after transplantation
Key secondary outcomes 0.1.1. Incidence of dose limiting toxicity
1. Adverse events
2. Continuous administration period
3. Determination of minimal residual disease (MRD) after administration of dasatinib
4. BCR-ABL mutation analysis in recurrent cases

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The subjects are those expecting allogeneic hematopoietic stem cell transplantation for Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia and whose pretransplantation BCR-ABL is positive on nested polymerase chain reaction (PCR).
Interventions/Control_2 The controls are those expecting allogeneic hematopoietic stem cell transplantation for Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia and whose pretransplantation BCR-ABL is negative on nested polymerase chain reaction (PCR).
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
16 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1). Eligibility criteria for enrollment of patients
1.Patients aged 16 years or older and 70 years or younger at the time of informed consent
2.Patients who have been diagnosed as having Ph+ALL and are expecting allogeneic hematopoietic stem cell transplantation
3.Patients whose MRD has been determined immediately before pretransplantation treatment
4.Patients who have given their own informed consent to participate in the study.

2). Eligibility criteria for starting administration of dasatinib
1.Acute GVHD at initiation of dasatinib administration is lower than Grade II
2.No lung disorder present in chronic GVHD at initiation of dasatinib administration
3.The platelet count is 100,000/ul or higher at initiation of dasatinib administration.
4.ECOG performance status of less than 2.
5.Functions of the primary organs are maintained.
6.No pleural effusion observed.
7.The patient's own informed consent to participate in the study has been obtained in writing, and the intention of withdrawal has not been expressed thereafter.

Key exclusion criteria 1.Ph+ALL patients with T315I
2.Patients who have increased or added immunosuppressants because of exacerbation of GVHD within 2 weeks before initiation of dasatinib administration
3.Patients who are negative for pretransplantation MRD and remain negative even after transplantation
4.Patients in whom infiltration of leukemia cells into the central nervous system cannot be controlled
5.Patients with poorly-controlled diabetes mellitus in spite of continuous use of insulin
6.Patients with poorly-controlled hypertension in spite of the use of antihypertensive drugs
7.Patients with uncontrollable infection
8.Patients with sinusoidal obstruction syndrome (SOS)
9.Patients with uncontrollable thrombotic microangiopathy (TMA)
10.Patients with active double cancer
11.Patients with psychiatric symptoms
12.Other patients who are deemed to be ineligible by the investigator
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Okamoto
Organization Keno University School of Medicine
Division name Division of Hematology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email okamoto@a7.keio.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Onizuka
Organization Tokai University School of Medicine
Division name Hematology and Oncology
Zip code 359-1143
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Homepage URL
Email moni5@mac.com

Sponsor
Institute Kant Study Group for Cell Therapy
Institute
Department

Funding Source
Organization Bristol Myers Squib
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 Tokai University School of Medicine, Hematology and Oncology
Address 143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
Tel 0463-93-1121
Email moni5@mac.com

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
2016 Year 11 Month 28 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
2016 Year 06 Month 15 Day
Date of IRB
2016 Year 06 Month 24 Day
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
2021 Year 12 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
2016 Year 11 Month 28 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028790

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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