UMIN-CTR Clinical Trial

Public title

Phase II trial using imatinib combined with chemotherapy for newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)

Acronym

Phase II trial using imatinib combined with chemotherapy for Ph+ALL

Scientific Title

Phase II trial using imatinib combined with chemotherapy for newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)

Scientific Title:Acronym

Phase II trial using imatinib combined with chemotherapy for Ph+ALL

Region

Japan

Condition

Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the efficacy and toxicity in patients with Ph+ALL treated with combinatory administration of imatinib with chemotherapy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Two-year event free survival. Events are defined as any induction failure, relapse or death of any reason.

Key secondary outcomes

1) Complete remission rate
2) Rate of adverse events
3) Five year overall survival
4) Conversion rate of BCR-ABL product, time to MRD negativity, time to reappearance of MRD and the mutation status of the gene.
5) Efficay and toxicity of transplantation

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

Induction
CPM 1.2 g/m2 (*800 mg/m2) day 1
DNR 60 mg/m2 (*30 mg/m2) day 1-3
VCR 1.3 mg/m2 (max 2 mg)day 1,8,15,22
PSL 60 mg/m2 PO on day 1-21 (*7) tapered
Imatinib 600 mg/body/day on day 8-42
MTX 15 mg + Ara-C 40 mg + DEX 4 mg/body IT on day 29
(*optional age 60-64)

Consolidation 1
MTX 1 g/m2 24hr-DIV on day 1
Ara-C 2 g/m2 (*1 mg/m2) 4 doses q 12h on day 2,3
mPSL 50 mg/body bid IV on day 1-3
Imatinib 600 mg/body/day on day 4-21
MTX 15mg/body + Ara-C 40mg/body + DEX 4mg/body IT on day 1

Consolidation 2
CPM 1.2 g/m2 on day 1
DNR 60 mg/m2 on day 1
VCR 1.3 mg/m2 (max 2 mg) on day 1
PSL 60 mg/m2 on day 1-7
Imatinib 600 mg/body/day on day 2-21
MTX 15 mg/body + Ara-C 40 mg/body + DEX 4 mg/body IT on day 1

Maintenance
Imatinib 600 mg/body/day on day 1-28
VCR 1.3 mg/m2 (max 2 mg) on day 1
PSL 60 mg/m2 on day 1-5

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

15

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Informed as ALL
2) Performance Status (ECOG):0-3
3) Total bilirubin <2.0 mg/dL
4) Creatinine <2.0 mg/dL
5) ECG showed no arrythmia of more than grade 3 by CTCAE
6) Obtained written informed consent

Key exclusion criteria

1) Infectious disease of Grade 4
2) Positive HIVAb or HBsAg
3) Active cancer other than ALL
4) Female patients who are pregnant or breast-feeding
5) Reject by responsible physician

Target sample size

66

Name of lead principal investigator

1st name
Middle name
Last name	Hideki Akiyama

Organization

Tokyo Metropolitan Komagome Hospital

Division name

Hematology Division

Zip code

Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

TEL

03-3823-2101

Email

Name of contact person

1st name
Middle name
Last name	Hideki Akiyama

Organization

Tokyo Metropolitan Komagome Hospital

Division name

Hematology Division

Zip code

Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

TEL

03-3823-2101

Homepage URL

http://www.jalsg.jp/

Email

hakiyama@cick.jp

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name

Organization

Ministry of Health, Labor and Welfare, "Study on establishment of the standard therapy to adult refractory leukemia"

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

2008

Year

07

Month

07

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

Open public recruiting

Date of protocol fixation

2008

Year

06

Month

21

Day

Date of IRB

Anticipated trial start date

2008

Year

08

Month

01

Day

Last follow-up date

2016

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

07

Month

01

Day

Last modified on

2009

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001468