UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007281
Receipt number R000008514
Scientific Title Safety and efficacy of reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies
Date of disclosure of the study information 2012/02/13
Last modified on 2014/02/06 11:47:53

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Basic information

Public title

Safety and efficacy of reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies

Acronym

GHSG-SCT1101

Scientific Title

Safety and efficacy of reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies

Scientific Title:Acronym

GHSG-SCT1101

Region

Japan


Condition

Condition

Acute myeloid leukemia(AML), Myelodysplastic syndrome(MDS), Acute lymphoblastic leukemia(ALL), Malignant lymphoma(ML), chronic myeloid leukemia(CML)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the safety and efficacy of related and unrelated bone marrow or peripheral blood stem cell transplantation, or cord blood transplantation using reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies who is ineligible for conventional myeloablative regimen due to high age between 55 and 70 years or even aged 20 - 55 years with significant comorbidity.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Donor cell engraftment rate and survival rate at 60 days after transplantation

Key secondary outcomes

1) Completion rate of conditioning regimen and protocol
2) Incidence of grade 3 or higher adverse events within 60 days after transplantation
3) Achievement rate of complete donor chimaerism within 100 days after transplantation
4) Non-relapse mortality within 100 days after transplantation
5) Incidence of infection within 1 year after transplantation
6) Incidence and severity of chronic GVHD within 1 year and 2 years after transplantation
7) Relapse rate within 1 year and 2 years after transplantation
8) Disease free survival within 1 year and 2 years after transplantation
9) Overall survival within 1 year and 2 years after transplantation
10) Subgroup analysis of donor source
11) Subgroup analysis of underlying disease


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
1) HLA matched related BM or PBSC donor
Fludarabine (Flu) 150mg/m2 + Cytarabine arabinoside (AraC) 8-16g/m2 + Cyclophosphamide (Cy) 50mg/kg
2) HLA mismatched related BM or PBSC donor and unrelated BM donor
Flu 150mg/m2 + AraC 8-16g/m2 + Cy 50mg/kg +- TBI 2Gy
3) Cord blood
Flu 150mg/m2 + AraC 8-16g/m2 + Cy 50mg/kg +- TBI 2Gy x2


GVHD prophylaxis:
1) HLA matched related BM or PBSC donor
Cyclosporine + short-term methotrexate(MTX)(day 1: 10mg/m2, day 3, 6: 7mg/ m2)
2) HLA mismatched related BM or PBSC donor and unrelated BM donor
Tacrolimus + short-term MTX(day 1: 10mg/m2, day 3, 6, 11: 7mg/m2, administration of MTX on day11 may be omitted by each physician's decision.)
3) Cord blood
Cyclosporine + short-term MTX(day 1: 10mg/m2, day 3, 6: 7mg/m2)

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients diagnosed as hematological malignancies who meet the following conditions,
a)AML
1.AML in advanced stage beyond CR1, received more than one course of chemotherapy to achieve CR, in high risk disease category according to SWOG/ECOG criteria, or in non-CR including relapse after auto or allo-SCT.
2.AML who have less than 30% bone marrow blasts at the registration.
b)MDS in poor prognosis group with WPSS high or very high, relapse after remission (including transplantation), or required platelet or red cell transfusions)
b)ALL
1.ALL in CR1 with a poor prognostic factor, in >=CR2, received more than one course of chemotherapy to achieve CR, in non-CR including relapse after auto or allo-SCT, or Ph+ALL in CR1 without achievement of MR.
2.ALL who have less than 30% bone marrow blasts at the registration.
d) ML
1.One of the following type of the histological type (WHO classification)
Precursor B- and T-cell neoplasms
Mature B-cell neoplasms
Mature T-cell and NK-cell neoplasms
Hodgkin lymphoma
2.ML who did not achieve PR after first-line chemotherapy, first relapsed ML who did not achieve PR after first-line salvage therapy , second relapsed ML, or in non-CR including relapse after auto-PBSCT.
e)CML
1.CML in CP with resistance to TKI or the T315I mutation, second or subsequent CP, AP, BP, or relapsed in non-CP including relapse after auto or allo-SCT.
2.CML who have less than 30 % bone marrow blasts at the registration.
2)Aged from 55 to 70 years old or aged from 20 to 55 years old with significant comorbidity.
3)Patients who have available donors (HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM, less than 2 antigen-mismatched CB with more than 2x10^7/kg)
4)ECOG performance status 0-2
5)Patients who have no severe organ dysfunction (T.Bil<2.0mg/dl, AST, ALT<=2.5xULN, Cr<2.0mg/dl, EF>50%, SpO2>95%)
6)Patients who give a written informed consent
7)Patients who are evaluated to be able to survive more than 3 months

Key exclusion criteria

1) Patients with HIV
2) Patients who received gemtuzumab ozogamicin within 3 months
3) Patients with another active malignancy
4) Patients with severe mental disease
5) Patients with severe central nervous system (CNS) lesions (except for CNS lesions of the underlying disease)
6) Patients with active infection
7) Patients who have history of chemotherapy within 21 days before transplantation (except hydroxyurea, cytarabine, or etoposide therapy for blast control)
8) Patients who have hypersensitivity to drugs included in this protocol
9) Patients who are judged inappropriate for the entry into the study by the principle doctor.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Tsurumi

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Yanagido Gifu

TEL

058-230-6000

Email

htsuru@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuhiro Kanemura

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Yanagido Gifu

TEL

058-230-6008

Homepage URL


Email

nkane@orion.ocn.ne.jp


Sponsor or person

Institute

Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Gifu University Hospital First Department of Internal Medicine

Organization

Division

Category of Funding Organization

Self funding

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

岐阜大学医学部附属病院(岐阜県)
岐阜市民病院(岐阜県)
岐阜赤十字病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Open public recruiting

Date of protocol fixation

2011 Year 03 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 13 Day

Last modified on

2014 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008514


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name