UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of Cord blood transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF.
Title of the study (Brief title)	JSCT-FB13 CB
Region	Japan

Condition
Condition	AML,MDS
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and efficacy of Cord blood transplantation using 180mg/m2 of fludarabine, 12.8mg/kg of intravenous busulfan, cytarabine and G-CSF for elderly patients aged 55-70 with AML or MDS.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Event-free survival at 1 year after transplantation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Conditioning regimen: G-CSF day-8--day2 200µg/m2+ Cytarabine day-7-day-4 100mg/m2+Flu 180mg/m2 + ivBu 12.8mg/kg + TBI 2Gy X 2 GVHD prophylaxis: tacrolimus + oral mycophenolate mofetil (MMF)(30mg/kg/day in two divided doses, from day -1 to 30, and subsequently tapered and discontinued within 2 weeks, privided that there is no active GVHD requiring treatment)
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	55 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation. 2. Age: 15-65 years old. 3. 2nd CR or subsequent CR, non CR. 1st CR as defined at least one of the following: a) Acute lymphoblastic leukemia Poor risk as defined by NCCN guidelines b) Acute Myelogenous Leukemia Greater than 1 cycle of induction therapy required to achieve remission High risk as defined by NCCN guidelines Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15) Preceding myelodysplastic syndrome c) Myelodysplastic syndrome high, very high as defined by WHO classification-based Prognostic Scoring System Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month. 4.HLA matched or less than 3 antigen-mismatched CB with more than 2 X 10^7/kg nucleated cells. 5.ECOG PS:0-2 6.Those who have no severe organ dysfunction (T. Bil<2.0mg/ml, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%) 7.Those who give written informed consent following sufficient explanation. 8.Those who are evaluated to be able to survive more than 3 months.
Key exclusion criteria	1.Those who are positive for anti-HIV antibody 2.Those who have history of gemtuzumab ozogamicin (MylotargTM) use within 4 months 3.Those who have coinciding active malignancies 4.Those who have uncontrolled psychiatric disorder 5.Those who have active infection 6.Those who have prior hematopoietic stem cell transplantation 7.Those who have history of chemotherapy within 30 days before transplant 8.Those who have hypersensitivity to drugs included in this protocol therapy 9.Those who are considered as inappropriate to register by attending physicians.
Target sample size	30

Research contact person
Name of lead principal investigator	Naoya Uchida
Organization	Toranomon Hospital, Tokyo, Japan
Division name	Department of Hematology
Address	2-2-2,Toranomonn,Minato-ku,Tokyo,Japan
TEL
Email

Public contact
Name of contact person
Organization	JSCT
Division name	FB13 datacenter
Address
TEL
Homepage URL
Email	jsct-office@umin.ac.jp

Sponsor
Institute	JSCT
Institute
Department

Funding Source
Organization	Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
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	2013 Year 05 Month 12 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 27 Day
Anticipated trial start date	2013 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 12 Day
Last modified on	2018 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012504