UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025028 |
|---|---|
| Receipt number | 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 11:45:42 |
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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
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
moni5@mac.com
Sponsor or person
Institute
Kant Study Group for Cell Therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028790
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