UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004211
Receipt number R000005059
Scientific Title A phase II study of Cord blood transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan.
Date of disclosure of the study information 2010/09/15
Last modified on 2018/03/21 15:26:27

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Basic information

Public title

A phase II study of Cord blood transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan.

Acronym

JSCT-FB10 CB

Scientific Title

A phase II study of Cord blood transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan.

Scientific Title:Acronym

JSCT-FB10 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 efficacy of Cord blood transplantation using 180mg/m2 of fludarabine and 12.8mg/kg of intravenous busulfan 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:
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 0 to 30, and subsequently tapered and discontinued within 2 weeks,provided 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 diagnosed as AML or MDS who meet the following conditions,
(a)Patients with AML(except M3)who are in advanced stage beyond first complete remission, are in high risk disease category according to SWOG/ECOG criteria, received more than one course of chemotherapy to achieve complete remission, AML/MLD in first remission, or AML with prior history of myelodysplastic syndrome
(B)Patients with MDS who are in poor prognosis group with high or very high score according to WHO classification-based prognostic scoring system, or required platelet transfusions of at least 10 units/week or red cell transfusions of at least 2 units/month.
2.Age:55-70
3.HLA matched or less than 3 antigen-mismatched CB with more than 2 X 10^7/kg nucleated cells.
4.ECOG PS:0-2
5.Those who have no severe organ dysfunction (T. Bil<2.0mg/dL, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%)
6.Those who give written informed consent following sufficient explanation.
7.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 (except hydroxycarbamide or cytarabine therapy for blast control)
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

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoya Uchida

Organization

Toranomon Hospital, Tokyo, Japan

Division name

Department of Hematology

Zip code


Address

2-2-2,Toranomonn,Minato-ku,Tokyo,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

JSCT

Division name

FB10 datacenter

Zip code


Address


TEL


Homepage URL


Email

jsct-office@umin.ac.jp


Sponsor or person

Institute

Japan Study Group for Cell Therapy and Transplantation

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

142 elderly patients (88 men and 54 women; median age, 61 years; range, 55-70 years) were participated, 103 AML and 39 MDS. 21 received related bone marrow (BM) or peripheral blood (PB), 50 did unrelated BM, and 71 did cord blood (CB). 105 (74%) experienced grade III or greater toxicities including 4 SOS. Neutrophil engraftment was achieved in 70 out of 71 related BM/PB or unrelated BM recipients, and 61 of 71 UCB recipients. Cumulative incidences of relapse and non-relapse mortality after 2 years were 24 % and 24.1%, respectively. Overall and event-free survivals at 2 years were 53.3% and 47.4 %, respectively. 2-year OS was 61.5% in related BM/PB, 67.8% in UBM, and 40.8% in CB recipients, showing inferior OS in CB recipients to the other donor types (P<0.05). However, for those in good performance status (ECOG 0) and had low blast count in BM (<5%), the differences became not significant (2-year OS were 77.3% in related BM/PB, 68.4% in UBM, and 65.0% in CB recipients).
Conclusion: The myeloablative dose of ivBu was well tolerated without increased toxicity-related mortality. The differences between CB and the others could likely be due to relatively poor conditions of CB recipients. This trial was registered as #UMIN000002426, #UMIN000004213, and #UMIN000004211.

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

Main results already published

Date of protocol fixation

2010 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 08 Month 27 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 15 Day

Last modified on

2018 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name