UMIN-CTR Clinical Trial

Public title

Phase I/II clinical study of WT1 peptide-based immunotherapy combined with Imatinib for chronic myelogeneous leukemia

Acronym

Phase I/II clinical study of WT1 peptide-based immunotherapy combined with Imatinib for CML

Scientific Title

Phase I/II clinical study of WT1 peptide-based immunotherapy combined with Imatinib for chronic myelogeneous leukemia

Scientific Title:Acronym

Phase I/II clinical study of WT1 peptide-based immunotherapy combined with Imatinib for CML

Region

Japan

Condition

Chronic myelogeneous leukemia
CML

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

(Phase I)
Safety
(Phase II)
Efficacy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(Phase I)
Safety is evaluated by NCI-CTCAE v3.0.
(Phase II)
Hematological Response
Cytogenetic Response
Molecular Response

Key secondary outcomes

Immune response to WT1

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

Vaccine

Interventions/Control_1

The patient is intradermally injected with 1 mg of the HLA-A*2402-restricted, modified 9-mer WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed 4 times at biweekly intervals. Imatinib is given daily accoring to privious doses.
The safety and efficacy are evaluated from 1 to 3 weeks after 4th WT1 vaccination .

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

16

years-old

<=

Age-upper limit

80

years-old

>

Gender

Female

Key inclusion criteria

1. Diagnosed as CML
2. Informed about his diagnosis
3. HLA-A*2402 positive
4. No chemotherapy/radiation except Imatinib has been performed within 4 weeks before the start of vaccination.
5. Dose of Imatinib has not been changed within 4 weeks
6. Require a minimum of 18 months elapse
7. Status of diasese is chronic phase.
8. His diasese is not changed within 3 months .
9. Meet the following criteria Neutrophil more than 1,500/microliter, Platelet more than 100,000/microliter, Hemoglobin more than 8g/dl
10. Aged 16 and over, and 79 and under
11. Performance Status (ECOG) 0-1
12. Adverse effect by Imatinib is tolatated.
13. Meet the following criteria for organ functions
Serum creatinine less than 1.5 folds of the upper normal limit.
Serum bilirubin less than 1.5 folds of the upper normal limit
Serum AST/GOT less than 3 folds of the upper normal limit
Arterial oxygen saturation more than 94% in room air
14. ECG: no severe abnormality
15. Informed consent has been obtained
16. Survival period is expected more than 3 months.

Key exclusion criteria

1. Post allogeneic hematopoietic stem cell transplantation
2. There is deep-seated active infection.
3. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.
4. Patients who have complications that are considered inappropriate for the trial.
5. Pregnant or lactating woman
6. There is severe psychiatric disorder.
7. There are other active malignancies.
8. Responsible doctors judged the patient inappropriate for the trial.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Haruo Sugiyama

Organization

Osaka University Graduate School of Medicine

Division name

Department of Functional Diagnosis

Zip code

Address

1-7, Yamada-oka, Suita City, Osaka , Japan

TEL

06-6879-2593

Email

sugiyama@sahs.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshihiro Oka

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cancer Immunotherapy

Zip code

Address

2-2, Yamada-oka, Suita City, Osaka, Japan

TEL

06-6879-3676

Homepage URL

Email

yoshi@cit.med.osaka-u.ac.jp

Institute

Department of Cancer immunotherapy, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

2010

Year

04

Month

19

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

2007

Year

12

Month

14

Day

Date of IRB

Anticipated trial start date

2008

Year

01

Month

01

Day

Last follow-up date

2013

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

19

Day

Last modified on

2014

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004250