UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002089
Receipt number R000002484
Scientific Title Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation
Date of disclosure of the study information 2009/06/18
Last modified on 2013/12/21 09:37:25

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Basic information

Public title

Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation

Acronym

WT1 vaccine for high risk leukemia after HSCT - Phase 1

Scientific Title

Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation

Scientific Title:Acronym

WT1 vaccine for high risk leukemia after HSCT - Phase 1

Region

Japan


Condition

Condition

Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, Myelodysplastic syndrome with high risk of relapse and/or excess blasts

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Assess the feasibility of WT1 peptide vaccine therapy for patients with increasing WT1 expression after hematopoietic stem cell transplantation and determine the optimal dose for phase 2 study.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety and the immunological optimal dose of WT1 vaccine.

Key secondary outcomes

Efficacy, Over all survival, Progression free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

WT1 peptide vaccine

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, or Myelodysplastic syndrome with high risk of relapse (IPSS >=int-2 or WPSS >=high) or excess blasts (RAEB (FAB), RAEB-t (FAB), RAEB-1 (WHO2008), or RAEB-2 (WHO2008)).
2. Patients in hematological complete remission after allogeneic hematopoietic stem cell transplantation.
3. Patients with any one of HLA-A0201, HLA-A0206 or HLA-A2402 genotype.
4. Patients with confirmation of WT1 expression in the peripheral blood (>50copy/ugRNA) or bone marrow (>1500copy/ugRNA) by real-time PCR assay at any time after the diagnosis of leukemia.
5. More than 28 days from reducing immunosuppressive drugs to 3mg/kg of cyclosporin or 0.1mg/kg of tacrolimus and 10 mg/body of prednisolone or less.
6. Patients with ECOG performance status of 0 to 2
7. Patients aged 20 years old and above with no upper limit.
8. Patients with well preserved main organ function. (bone marrow, heart, lung, liver, kidney etc.)
Neutrophils above 1,000
Platelets above 50,000
GOT less than 5-times the upper limit of normal
GPT less than 5-times the upper limit of normal
Bilirubin less than 3-times the upper limit of normal
Serum creatinine less than 3-times the upper limit of normal
Saturation above 95% at room air
No electrocardiogram abnormalities which requires treatment.
9. Patients who are expected to survive for at least 3 months.
10. Patients with written informed consent.

Key exclusion criteria

Patients with any one of the criteria are ineligible.
1. Patients with active acute GVHD or extended chronic GVHD (including bronchiolitis obliterans or bronchiolitis obliterans organizing pneumonia).
2. Patients receiving over permitted dose of immunosuppressive drugs or corticosteroids .
3. Patients with active infection including positive cytomegalovirus antigenemia which requires treatment.
4. Patients with positive HBs antigen, or HCV antibody. Patients with active hepatitis or cirrhosis.
5. Pregnant or breast feeding patients. Patients who have a possibility of pregnancy or desire for baby.
6. Patients with active autoimmune disease (including hypothyroidism, idiopathic thrombocytopenic purpura, autoimmune hepatitis) or with a history of those diseases.
7. Patients with active interstitial pneumonia or its history.
8. Patients with a history of allergy or severe adverse reaction against biological agents.
9. Patients with a severe psychological disorder and considered unable to obtain informed consent for the study.
10. Patients with uncontrollable central nervous invasion.
11. Patients participating in other clinical trials*.
* If the safety and anti-tumor effect of vaccine therapy is obviously not considered to be affected by the other clinical trials, the patient doesn't need to be excluded.
12. Patients who are considered ineligible for the study.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Heike

Organization

National Cancer Research Center Hospital

Division name

Department of Clinical Trial Coordination and Developmental Therapeutics

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

National Cancer Research Center Hospital

Division name

Support Center for Patients and Families

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

03-3547-5293

Homepage URL


Email



Sponsor or person

Institute

National Cancer Research Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

国立がん研究センター中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 18 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

2008 Year 09 Month 29 Day

Date of IRB


Anticipated trial start date

2009 Year 02 Month 01 Day

Last follow-up date

2014 Year 12 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 06 Month 18 Day

Last modified on

2013 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=R000002484


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name