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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037944
Receipt No. R000043239
Scientific Title ATG-based HLA haploidentical stem cell transplantation (HCM regimen) for recurrent or refractory round-cell-type sarcoma in AYA generation: prospective phase II study
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/05

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Basic information
Public title ATG-based HLA haploidentical stem cell transplantation (HCM regimen) for recurrent or refractory round-cell-type sarcoma in AYA generation: prospective phase II study
Acronym ATG-based HLA haploidentical stem cell transplantation (HCM regimen) for recurrent or refractory round-cell-type sarcoma in AYA generation
Scientific Title ATG-based HLA haploidentical stem cell transplantation (HCM regimen) for recurrent or refractory round-cell-type sarcoma in AYA generation: prospective phase II study
Scientific Title:Acronym ATG-based HLA haploidentical stem cell transplantation (HCM regimen) for recurrent or refractory round-cell-type sarcoma in AYA generation
Region
Japan

Condition
Condition round-cell-type sarcoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether HLA haploidentical stem cell transplantation (Hyogo regimen) can improve the survival prognosis of AYA-generation patients with recurrent or refractory round-cell-type sarcoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Median survival time (MST) in registration period (8 years) and follow-up period (2 years)
If the lower limit of 95% CI of the MST is over 0.82 years, which is the MST of relapsed rhabdomyosarcoma (JCO. 1999; 17: 3487-3493), this study is defined as "positive study".
Key secondary outcomes Safety
1) Engraftment rate on day 35. Engraftment is defined as neutrophil > 500/microL with >90% donor origin. Rejection is defined when engraftment is not achieved within day 35 after transplantation.
2) Acute GVHD within day 100
3) Complications including thrombotic microangiopathy (TMA)
4) Other adverse events assessed using CTCAE

Efficacy
5) Response rate assessed using iRECIST. Assessment using RECIST ver. 1.1 is also documented for comparizon with other studies
6) Relapse rate
7) Disease-free survival (DFS) or progression-free survival (PFS)

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 The basic structure of the conditioning regimen was applied from our haploidentical stem cell transplantation (Hyogo regimen) for hematological malignancies, consisting of fludarabine at 30 mg/m2/day for 6 days (days -9 and -4), melphalan at 70 mg/m2/day for 2 days (days -3 and -2), rabbit anti-thymocyte globulin (ATG, thymoglobulin, Sanofi) at 1.25 mg/kg/day for 2 days (days -2 and -1), and 3 Gy of total body irradiation. To prevent anaphylaxis caused by ATG and stem cell infusions, methylprednisolone (mPSL) was administered at 2 mg/kg/day and 500 mg/body/day on days -2 and -1 and days 0 and 1. GVHD prophylaxis consists of continuous infusion of tacrolimus with a target concentration of 10-12 ng/mL from day -3 and mPSL 1 mg/kg/day after day 2. The stem cell source used was peripheral blood stem cells, which were infused on days 0 and 1, targeting 5-10*10e6/kg of CD 34+ cells, without being frozen.
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
15 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria 1) Recurrent or refractory rhabdomyosarcoma with alveolar or pleomorphic type
2) Recurrent or refractory Ewing family sarcoma
3) desmoplastic small round cell tumor (any stage)
Key exclusion criteria 1) serum Cre >2.0 mg/dl
2) serum T-bil >2.0 mg/dl
3) serum AST and/or ALT >200 mg/dl
4) EF <40% by ultracardiograpgy
5) SpO2 <90% in ambient air
6) PS (ECOG score) 3-4
Not always excluded if data are elevated due to original disease and are expected to improve by treatment
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Ikegame
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo 663-8501, Japan
TEL 0798456886
Email rinri@hyo-med.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Ikegame
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo 663-8501, Japan
TEL 0798456886
Homepage URL
Email haplo@hyo-med.ac.jp

Sponsor
Institute Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department

Funding Source
Organization partially supplied by Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Hyogo College of Medicine
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo, Japan
Tel 0798456066
Email rinri@hyo-med.ac.jp

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
2019 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 10 Day
Last follow-up date
2029 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 05 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043239

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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