UMIN-CTR Clinical Trial

Public title

Phase 2 study of the treatment discontinuation after the change from 2nd tyrosine kinase inhibitors to Interferon-alpha in chronoic myeloid leukemia patients who maintained molecular remission.

Acronym

SAIS (Second TKI and Interferon Stop study)

Scientific Title

Phase 2 study of the treatment discontinuation after the change from 2nd tyrosine kinase inhibitors to Interferon-alpha in chronoic myeloid leukemia patients who maintained molecular remission.

Scientific Title:Acronym

SAIS (Second TKI and Interferon Stop study)

Region

Japan

Condition

Chronic myeloid leukemia (CML) in 1st chronic phase and MR4.0 with complete molecular response (CMR) sustained for more than 2 years with 2nd generation tyrosine kinase inhibitors (TKIs).

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose is to whether MMR is sustained after the stop of the interferon-alpha which is administered for 1 year following with the discontinuation of 2nd TKIs in Philadelphia chromosome positive CML patients who maintained MMR for more than 2 years with 2nd TKIs.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Among evaluable patients, the ratio of patients who maintained MMR 12 months after stop of IFN (Molecular relapse-free survival; MoRFS).

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of IFN is started at a dose of 3 million units 2-3 times per week within 4 weeks after discontinuation of nilotinib or dasatinib treatment. Then, after sustained MMR by IFN for 1 year, IFN treatment is ceased.

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients with Philadelphia chromosome-positive or bcr-abl fusion transcript-positive CML 1st chronic phase and in CMR maintained for longer than 2 years under 2nd TKIs.
2) ECOG Performance status 0,1,2
3) Adequate end organ function as defined by:
i) ALT and AST < 2.5 X ULN (upper limit of normal)
ii) T.Bil < 1.5 X ULN
iii) Cr < 1.5 x ULN
iv) SpO2 under room air = or > 95%
4) Ability to provide written informed consent prior to any study procedures being performed.

Key exclusion criteria

1) Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
2) Patients with uncontrolled active infection.
3) Patients with suspicion of interstitial pneumonitis.
4) History of depression.
5) Patients with uncontrolled diabetes.
6) Patients who currently receiving systemic treatment with corticoid or immunosuppressive drugs.
7) Patients whose physicians consider not appropriate.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Kensuke Usuki

Organization

NTT Medical Center Tokyo

Division name

Department of Hematology

Zip code

Address

Higasigotanda, 5-9-22, Shinagawa-ku,Tokyo, Japan Zip code 141-8625

TEL

03-3448-6111

Email

kensuke.usuki@gmail.com

Name of contact person

1st name
Middle name
Last name	Kensuke Usuki

Organization

NTT Medical Center Tokyo

Division name

Department of Hematology

Zip code

Address

Higasigotanda, 5-9-22, Shinagawa-ku,Tokyo, Japan Zip code 141-8625

TEL

03-3448-6111

Homepage URL

Email

kensuke.usuki@gmail.com

Institute

CML Cooperative Study Group

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

2015

Year

01

Month

05

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

Terminated

Date of protocol fixation

2014

Year

08

Month

07

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

26

Day

Last modified on

2017

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018669