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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027821
Receipt No. R000031865
Scientific Title Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15).
Date of disclosure of the study information 2017/07/01
Last modified on 2017/12/19

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Basic information
Public title Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15).
Acronym AML-SCT5
Scientific Title Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15).
Scientific Title:Acronym AML-SCT5
Region
Japan South America

Condition
Condition acute myeloid leukemia (AML)
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate safety and efficacy of reduced-intensity/toxicity stem cell transplantation using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a substantial myeloablative conditioning regimen (FLAMEL) for children with high-risk AML in first complete remission or AML in second complete remission.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Probability of overall survival rate at three years after transplantation
Key secondary outcomes 1) Efficacy
Probability of event-free survival (EFS) rate,
Cumulative incidence of relapse and
non-relapse mortality (NRM) at 3 years after transplantation
Probability of overall survival (OS) rate,
EFS rate,
Cumulative incidence of relapse and
NRM at 10 years after transplantation
Profile of cause of death at 3 and 10 years after transplantation
Incidence of second transplantation and
second malignant neoplasms
2) Short-term safety (up to 100 days after transplantation)
Cumulative incidence of engraftment,
secondary graft failure (2nd GF) and
NRM at 100 days after transplantation
Cumulative incidence and severity of acute and chronic graft-versus-host disease (GVHD),
sinusoidal obstruction syndrome (SOS) and thrombotic microangiopathy (TMA)
Incidence of and reason for donor lymphocyte infusion (DLI)
Monitoring of chimerism at 1 and 3 months after FLAMEL regimen
Profile of severe infectious disease after KIR ligand-mismatched cord blood transplantation
Profile of conditioning regimen-related toxicities (Bearman criteria) up to 4 weeks after transplantation
Profile of CTCAE (grade >=3)
Cumulative days of fever (>=38C)
3) Long-term safety
Cumulative incidence of engraftment,
2nd GF,
SOS and TMA up to 1 year after transplantation
Incidence of and reason for DLI up to one year after transplantation
Cumulative incidence and severity of acute and chronic GVHD
Monitoring of height (SD) and body weight (SD) after transplantation
Monitoring of height (SD) of patients untreated with growth hormone
Monitoring of TSH, free-T4, LH, FSH, testosterone, estradiol and anti-mullerian hormone
Monitoring of Tanner stage and menstruation
Incidence of growth disturbance, thyroid dysfunction and gonadal dysfunction at 3 and 10 years after transplantation
Profile of CTCAE (grade >=3) up to 1 year after transplantation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FLAMEL regimen: fludarabine (30 mg/m^2 x 1/day for 4 days), cytarabine (2 g/m^2 x 1/day for 4 days), melphalan (60 mg/m^2 x 1/day for 3 days) and low-dose total body irradiation (2 Gy x 1/day for one day)
Graft: any of bone marrow, peripheral stem cell and cord blood.
Graft-versus-host disease (GVHD) prophylaxis: in essentially tacrolimus or cyclosporine in combination with methotrexate.
Interventions/Control_2 For evaluation of secondary endo-points, patients received allogeneic transplantation using myeloablative conditioning regimens consisting of busulfan (> 8 mg/kg) or total body irradiation (>= 8 Gy, fractionated) are also enrolled to this study.
Graft: any of bone marrow, peripheral stem cell and cord blood.
Graft-versus-host disease (GVHD) prophylaxis: in essentially tacrolimus or cyclosporine in combination with methotrexate.

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

Not applicable
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria
1) 1) AML (acute promyelocytic leukemia, AML which developed in patients with Down syndrome, secondary AML, AML which developed in patients with myelodysplastic syndrome, NK/myeloid leukemia and granulocytic leukemia are excluded)
2) Cases registered in the prospective study in JPLSG (JPLSG CHM-14)
3) Patients with high-risk AML in first complete remission or bone marrow-relapsed patients with AML in second complete remission
4) High-risk AML
Any of the following
a) Unfavorable chromosome abnormality including -7, del(5q)/-5, t(16;21)(p11;q22)/FUS-ERG, t(9;22)(q34;q11.2)/BCR-ABL1 or t(6;11)(q27;q23)/MLL-MLLT4(AF6), or unfavorable genetic abnormality including FLT3-ITD or NUP98-NSD1
b) Blast ratio >=5% in the bone marrow (M2/M3 marrow) after the first induction therapy
c) Extramedullary lesions after the first induction therapy
5) Patients less than 18 years at the initial diagnosis in first remission, or patients less than 20 years at the relapse diagnosis in second remission
6) Written informed consent has been acquired from patients and/or persons with parental authority.
7) Cases in which a suitable donor is available and hematopoietic cell transplantation is considered to be mandatory
8) Patients whose performance status are 0 or 2 by ECOG criteria
9) Patients who satisfactory meet all of the following criteria about organ functions within 28 days prior to registration
a) Patients without uncontrolled cardiac failure and ejection fraction of left ventricle >= 50% by UCG
b) %VC >= 50% and FEV1.0% >= 50%, or SpO2 >= 95% by room air if pulmonary function tests are impossible
c) AST/ALT < 5 x upper limit of normal range (CTCAE < grade 2)
d) Patients without uncontrolled renal failure and sCr < 2 x upper limit of normal range
Key exclusion criteria Exclusion criteria
1) Patients who have extramedullary lesions at registry
2) Patients who have prior radiation therapy
3) Patients who have prior hematopoietic cell transplantation
4) Patients who have poorly controlled infectious disease
5) Patients who have psychiatric disorder
6) Patients who have coinciding malignancies
7) Patients who have an episode of hypersensitivity reactions against drugs used in conditioning regimens and/or GVHD prophylaxis
8) Pregnant women or women who may be pregnant
9) Patients who are considered as inappropriate for this trial by attending physicians

Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromasa Yabe
Organization Tokai University, School of Medicine
Division name Department of Cell Transplantation and Regenerative Medicine
Zip code
Address 143, Shimokasuya, Isehara, Japan
TEL 0463-93-1121
Email yabeh@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Ishida / Katsutsugu Umeda
Organization Kyoto City Hospital / Graduate School of Medicine, Kyoto University
Division name Department of Pediatrics / Department of Pediatrics
Zip code
Address 1-2, Higashitakada-cho, Mibu, Nakagyou-ku, Kyoto / 54, Kawahara-cho, Shogoin, Sakyou-ku, Kyoto
TEL 075-311-5311.075-751-3290
Homepage URL http://jplsg.jp/menu0_contents/index_menu_0.htm
Email ishidah@koto.kpu-m.ac.jp

Sponsor
Institute Japan Children's Cancer Group (JCCG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 日本小児血液・がん研究組織参加施設

Other administrative information
Date of disclosure of the study information
2017 Year 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 06 Month 19 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031865

Research Plan
Registered date File name

Research case data specifications
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Research case data
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