UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Title of the study (Brief title)	Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Region	Japan

Condition
Condition	Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult patients with hematological malignancies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Probability of survival with engraftment at 60 days post-transplant
Key secondary outcomes	Adverse events related to intra-bone-marrow injection, term to hematopoietic recovery, treatment-associated toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, transplant-related mortality, relapse rate, disease-free survival, overall survival, causes of death

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	Maneuver
Interventions/Control_1	Reduced-intensity conditioning followed byintra-bone-marrow cord blood transplantation
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	Not applicable
Gender	Male and Female
Key inclusion criteria	All of the following are required. (1)Adult patients with hematological malignancy who need allogeneic transplantation (2)Any of the following is required. 1.Age 55 or older 2.Patients with Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) of one or more between 16 and 55 years old 3.A prior history of hematopoietic stem cell transplantation (3)No suitable donor is available except unrelated cord blood. (4)Marrow blasts less than 70% (5)Written informed consent to participate the trial. (6)Performance status(ECOG) 0 or 1 (7)A cord blood unit matched at >4 of 6 HLA antigens (A, B, DR) and with cryopreserved total nucleated cell dose of >2 x 10E7/kg is available.
Key exclusion criteria	Any of the following. (1)Positive for HIV antibody or HBs antigen or HCV antibody (2)Patients treated with gemtuzumab ozogamicin within 6 months (3)Pregnant or during breast feeding (4)Patients with other malignant comorbidity (5)Uncontrolled psychiatric disease (6)Uncontrolled active infection (7)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen. (8)Impaired organ function (a)left ventricular ejection fraction smaller than 40% (b)FEV1.0 and TLC less than 30% (c)AST or ALT over 5xULN(NCI-CTCAE Grade 3) (d)serum creatinine over 3xULN(NCI-CTCAE Grade 3) (9)Re-transplant within 1 year from the previous transplantation (10)Cases that physicians judged as inappropriate.
Target sample size	22

Research contact person
Name of lead principal investigator	Makoto Murata
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Address	65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2145
Email	mmurata@med.nagoya-u.ac.jp

Public contact
Name of contact person	Makoto Murata
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Address	65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2145
Homepage URL
Email	mmurata@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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	名古屋大学医学部附属病院（愛知県）、金沢大学医学部附属病院（石川県）、岡山大学病院（岡山県）、新潟大学医歯学総合病院（新潟県）、北海道大学病院（北海道）、東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2007 Year 10 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 08 Month 21 Day
Anticipated trial start date	2007 Year 09 Month 01 Day
Last follow-up date	2016 Year 07 Month 26 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded	2017 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28582607
Results
Other related information

Management information
Registered date	2007 Year 10 Month 24 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001039