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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007281
Receipt No. 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

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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
Institute Gifu University Hospital
Institute
Department

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
URL(English) https://upload.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


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