UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002603
Receipt number R000003176
Scientific Title Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia
Date of disclosure of the study information 2009/10/13
Last modified on 2011/10/12 11:54:33

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Basic information

Public title

Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia

Acronym

JALSG GML208-P1

Scientific Title

Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia

Scientific Title:Acronym

JALSG GML208-P1

Region

Japan


Condition

Condition

acute myeloid leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the safety of gemtuzumab ozogamicin combined with BH-AC + DNR.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Estimation of maximum tolerated dose

Key secondary outcomes



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

Dose of GO(div day4) is determined at each level in combination with BH-AC(200mg/m2, day1-8) + DNR 30mg/m2, day1-3.

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

65 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Firstly relapsed or primary refractory CD33-positive acute myeloid leukemia (excluding M3)
2) No history of GO treatment
3) ages, 65-74
4) PS, 0-1
5) AST, ALT < 2.5-fold of upper limit of each institute
6) Total bilillubin < 1.5 mg/dL
7) Serum creatinine < 2.0 mg/dL
8) No ischmic sign or arrythmia to be treated on ECG
9 Left ventricular ejection fraction > 50%
10) PaO2 > 65mmHg or SaO2 > 93% (room air)
11) Expected to survive more than two months
12) Written consent after careful information including insufficient experience in our country

Key exclusion criteria

1) History of myelodysplastic syndromes or myeloproliferative neoplasms
2) Therapy-related leukemia
3) Infiltration on central nurvous system
4) Previous autologous or allogeneic stem cell transplantation
5) History of glaucoma
6) Diabetes mellitus currently treated with insulin
7) Uncontrollable hypertension
8) History of ischemic heart disease, cardiomyopathy or arrythmia currently treated
9) Interstitial pneumonia, pulmonary fibrosis, or svere emphysema
10) Positivity of HBs antigen, HCV antibody or human immunodeficiency virus
11) Active infectious disease
12) Liver cirrhosis
13) Double cancer
14) Difficulty of treatment based on mental illness

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshikazu Ito

Organization

Tokyo Medical University

Division name

Hematology Division

Zip code


Address

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Medical University

Division name

Hematology Division

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name



Funding Source

Organization

Japan Adult Leukemia Study Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 13 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

Completed

Date of protocol fixation

2008 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 01 Day

Last follow-up date

2011 Year 02 Month 01 Day

Date of closure to data entry

2011 Year 10 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 10 Month 08 Day

Last modified on

2011 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003176


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name