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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003942
Receipt No. 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

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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
Institute Saitama Medical Center,Jichi Medical University
Institute
Department

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
URL(English) https://upload.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


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