UMIN-CTR Clinical Trial

Public title

A feasible study of datsatinib for Ph ALL in maintenance use at post allogeneic stem cell transplantation (KSGCT1101/DASALL)

Acronym

Dasatinib in post HSCT Ph ALL (KSGCT1101/DASALL)

Scientific Title

A feasible study of datsatinib for Ph ALL in maintenance use at post allogeneic stem cell transplantation (KSGCT1101/DASALL)

Scientific Title:Acronym

Dasatinib in post HSCT Ph ALL (KSGCT1101/DASALL)

Region

Japan

Condition

Ph+ALL

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to estimate feasible initial dose level of dasatinib in patients with Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ALL) after hematopoietic stem cell transplantation, and to evaluate the efficacy and safety of dasatinib for all qualified cases.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Primary endpoint is a continuous administration successful execution ratio after an administration for four weeks.

Key secondary outcomes

(1) DLT frequencies (for initial four weeks each administration course, all administration course)
(2) Adverse event frequencies
(3) A continuous administration period
(4) A complete molecular remission (complete molecular response) rate after the dasatinib administration
(5) Overall survival one year later after transplantation
(6) Recurrence rate one year later after transplantation
(7) Pharmacokinetics

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The dose increase and decrease judgment in the first and second cohort
1. Three patients are enrolled in the first cohort (level 1). If continuous administration successful execution is three of three cases after an administration for four weeks, three patients will be enrolled with the dose escalation to level 2 in the second cohort. When continuous administration successful execution is observed after an administration in all three cases in level 2 for four weeks, three cases will be enrolled with dose escalation to level 3.
2. If in two of three cases, two patients will be enrolled in the second cohort at level 1 without being carried out. If together for four weeks, three patients will be enrolled in level 2 in the third cohort. If continuous administration successful execution is not observed after an administration by additional one of two patients, one more patient at level 1 will be enrolled in the third cohort. If continuous administration successful execution is not observed in both patients, three patients will be enrolled with dose reduction to level 0 in the third cohort.
3. If four weeks continuous administration successful execution is one of three cases, three patients will be enrolled in level 0 in the second cohort.
4. If continuous administration successful execution is none of three cases, case registration will be cancelled and will hold effect safety assessment Committee and review validity of the dose setting.

The dose modifications after the third cohort
1. After the third cohort, the dose will be calculated using CRM procedure with a statistical analysis person in charge based on continuous administration successful execution data after an administration observed in the first and second cohort sequentially for four weeks.

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

Age-lower limit

18

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Age at agreement acquisition between 18 and 65 years old
(2) Patients with Ph+ALL, and underwent allogeneic hematopoietic stem cell transplantation
(3) More than 100 days after transplant, and a donor blood corpuscle engraftin
(4) Acute GVHD being less than GradeII In the test value within 7 days from registration, as the following;
(5) Neutrophil count more than 1500/
(6) Platelet count more than 100,000/
(7) ECOG performance status being 0 or 1(8) Adequate end organ function being maintained
1. We meet the following standards with test value within 7th from a registration day
2. Total bilirubin < 5 x upper limit of normal, AST and ALT < 1.5 x upper limit of normal
3. Serum creatinine < 1.5 x upper limit of normal
4. More than 93% of percutaneous oxygen saturation
(9) Pleural effusion do not be detected (in chest simplicity photograph or chest CT)
(10) The agreement in the document being obtained from the person himself about participation in this study

Key exclusion criteria

(1) By the continuous use of insulin a case (diabetes that leaves when there is it more than 200 mg/dl of fasting blood glucose or) with the diabetes mellitus inadequate control
(2) The patients with positive one of HBs antigen, HCV antibody, HIV antibodies
(3) A case with hypertension that has poor control by the antihypertensive agent use
(4) The case that develops the infection that is impossible of control
(5) The case that develops sinusoid obstruction syndrome (SOS)
(6) The case that develops the thrombotic microangiopathy (TMA) that is impossible of control
(7) A case with the double cancer of the activity
(8) The case with the mental disorder that it is thought to be difficult to obtain effective consent
(9) It is a case with a history of the upper part, the lower digestive tract bleeding in the past
(10) In addition, the case that attending staff judged to be inappropriate

Target sample size

15

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

Email

ksgctdc@ksgct.net

Name of contact person

1st name
Middle name
Last name	Makoto Onizuka

Organization

Kanto Study Group for Cell Therapy

Division name

Trial Office

Zip code

Address

kanagawa

TEL

0463-93-1121

Homepage URL

Email

moni5@mac.com

Institute

Kanto Study Group for Cell Therapy

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

06

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

06

Month

01

Day

Date of IRB

2011

Year

03

Month

23

Day

Anticipated trial start date

2011

Year

06

Month

01

Day

Last follow-up date

2014

Year

11

Month

30

Day

Date of closure to data entry

2014

Year

12

Month

10

Day

Date trial data considered complete

2014

Year

12

Month

31

Day

Date analysis concluded

Other related information

Registered date

2011

Year

06

Month

16

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=R000006487