UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003942
Receipt number R000004725
Scientific Title Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for elderly patients with hematological malignancies: A phase I/II study
Date of disclosure of the study information 2010/09/01
Last modified on 2016/07/28 07:37:21

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Basic information

Public title

Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study

Acronym

Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study

Scientific Title

Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study

Scientific Title:Acronym

Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study

Region

Japan


Condition

Condition

1. Acute lymphoblastic leukemia with or without Philadelphia chromosome: any CR or non-CR with marrow blasts <50%.
2. Acute myeloid leukemia: any CR or non-CR with marrow blasts <50%.
3. Myelodysplastic syndrome: IPSS intermediate-II or high. Relapse after remission.
4. Malignant lymphoma
1) Indolent lymphoma (including Mantle cell lymphoma): Chemo refractory case
2) Aggressive lymphoma: PR1, >CR1, or good PR.
3) Highly aggressive lymphoma: any CR or good PR.

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To test the safety, and efficacy of Fludarabin and TBI combination for myeloablative conditioning for elderly patients with hematological malignancies (phase I/II study).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Non-hematological toxicities within 35days after HSCT(Phase I part).
One-year disease free survival rate (PhaseII part).

Key secondary outcomes

Graft failure
Regimen related toxicity (RRT)
Acute GvHD incidence and severity
Relapse
Non relapse mortality


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Flu 30mg/m2x4days+Total body irradiaition(TBI)for conditioning. Dose escalation study every 6 doses from 8Gy of TBI.

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

18 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1.Age: 55 to 65 years, or 18 to 55years not indicate for myeloablative conditioning due to complications such as past infection.
2.HLA matched or 1 Ag mismatched relate or unrelated donor.
3.ECOG 0-1
4.Cardiac: LV Ejection fraction>40% by Echocardiogram
Pulmonary: SpO2>94 % and FEV1.0%>70%.
Hepatic: total bilirubin>2.0 mg/dl and AST >2.5x ULN.
Renal: Serum creatinine clearance >30 ml/min

Key exclusion criteria

Drug allergy used for conditioning or GvHD prophylaxis.
Positive HBs antigen or seropositive to HIV. (Not exclude for seropositive to HCV)
Uncontrolled infection.
Patients inappropriate for transplantation with reasons other than above

Target sample size

51


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinobu Kanda

Organization

Saitama Medical Center,Jichi Medical University

Division name

Division of Hematology

Zip code


Address

1-847, Tenuma-cho,Omiya-ku, Saitama

TEL

048-647-2111

Email

ycanda-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Minagawa

Organization

Kobe University Hospital

Division name

Department of General Medicine

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6912

Homepage URL


Email

kminagaw@med.kobe-u.ac.jp


Sponsor or person

Institute

Saitama Medical Center,Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

自治医科大学さいたま医療センター 血液内科
山口県立総合医療センター 血液内科
北福島医療センター 血液内科
東北大学医学部 血液内科
松下記念病院 内科
和歌山大学医学部 血液内科
大阪大学医学部 血液・腫瘍内科
大阪市立大学医学部 血液内科
神戸大学医学部 腫瘍・血液内科
府中病院 血液内科
関西医科大学 血液内科
大阪医科大学 血液内科
兵庫医科大学 血液内科
京都府立医科大学 血液内科


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 01 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

2010 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2016 Year 04 Month 01 Day

Date analysis concluded

2016 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 07 Month 23 Day

Last modified on

2016 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name