UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective non-randomised phase II study to assess the safety and efficacy of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation for hematological malignancies (C-SHOT 0505)
Title of the study (Brief title)	A phase II study of melphalan combined with fludarabine for UBMT (C-SHOT 0505)
Region	Japan

Condition
Condition	Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome, Chronic myelomonocytic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to assess the safety and efficacy of melphalan combined with fludarabine as a reduced intensity-conditioning regimen for patients ineligible for conventional preparative regimen due to high age between 40 and 55 years or even under 40 years with significant co-morbidity who receive unrelated bone marrow transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival at 100 days after transplantation
Key secondary outcomes	Time to hematopoietic recovery, grade of treatment-related toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, overall survival at 1-year after transplantation, disease-free survival at 1-year after transplantation

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	Fludarabine 25mg/square meter for 5 days and melphalan 90mg/square meter for 2 days will be used as conditioning regimen. Subsequently, bone marrow graft from unrelated donor will be transplanted under immunosuppressive treatment with short-term methotrexate and tacrolimus.
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	16 years-old <=
Age-upper limit	55 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Either patients with AML or ALL or CML or MDS or CMMOL (except CML in blast crisis), (2)(a)Age between 40 and 55 years and, 1.Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) is 0-2 point at one month before the transplantation, (b)Age under 40 years, 1.serum bilirubin 1.5-3.0mg/dl or AST/ALT 2XULN and 5xULN, 2.serum creatinin 1.5-2.0mg/dl, 3.left ventricular ejection fraction 30-50%, 4.past history of cardiac event, 5.PaO2 50-90mmHg without oxygen inhalation, (3) Available of HLA-A/B/DRB1 identical or DRB1-genotypical or DR-serological 1-locus mismatched unrelated bone marrow donor, (4) First high dose therapy with hematopoietic stem cell support including auto transplantation, (5)PS 0-2, (6) Written informed consent to participate the trial
Key exclusion criteria	(1)Positive for HIV antibody and/or HBs antigen and/or HCV antibody, (2)Graft manipulation such as T-cell depletion, (3)history of administration of anti-neoplastic agent within 4 weeks before transplantation (4)30% or more tumor cells of total nucleated cell count in bone marrow specimen before 28 days of registration (5)Pregnant or during breast feeding, (6)Uncontrolled another neoplastic disease, (7)Uncontrolled active psychiatric disease,(8)Uncontrolled active infection, (9)central nervous system involvement of tumor cells (10)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, (11) Available of a suitable related donor, (12)Patients suggested as ineligible by their attending physician
Target sample size	54

Research contact person
Name of lead principal investigator	Yoshihisa Morishita
Organization	JA Aichi Konan Kosei Hospital
Division name	Department hematology and oncology
Address	137 Omatsubara,Takaya-cho,Konan,Aichi,Japan
TEL	0587-56-4155
Email	m59@mb.ccnw.ne.jp

Public contact
Name of contact person	Tetsuya Nishida
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2145
Homepage URL	http://www.c-shot.or.jp/study/0505
Email	tnishida@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization	Nagoya Blood and Marrow Transplantation Group
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

Other administrative information
Date of disclosure of the study information	2006 Year 07 Month 31 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2006 Year 07 Month 21 Day
Anticipated trial start date	2006 Year 08 Month 01 Day
Last follow-up date	2014 Year 10 Month 01 Day
Date of closure to data entry	2014 Year 12 Month 01 Day
Date trial data considered complete	2015 Year 02 Month 01 Day
Date analysis concluded	2015 Year 04 Month 01 Day

Related information
URL releasing protocol	http://www.c-shot.or.jp/study/0505/outline/
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2006 Year 07 Month 31 Day
Last modified on	2017 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000551