UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for elderly patients with hematological malignancies: A phase I/II study
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshinobu Kanda
Organization	Saitama Medical Center,Jichi Medical University
Division name	Division of Hematology
Address	1-847, Tenuma-cho,Omiya-ku, Saitama
TEL	048-647-2111
Email	ycanda-tky@umin.ac.jp

Public contact
Name of contact person	Kentaro Minagawa
Organization	Kobe University Hospital
Division name	Department of General Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004725