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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002069
Receipt No. R000002370
Scientific Title HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic diseases
Date of disclosure of the study information 2009/06/12
Last modified on 2016/03/28

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Basic information
Public title HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic diseases
Acronym HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic diseases
Scientific Title HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic diseases
Scientific Title:Acronym HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic diseases
Region
Japan

Condition
Condition Acute myeloid leukemia(AML)
Acute lymphoblastic leukemia (ALL)
Secondary acute myelogenous leukemia
Chronic myeloid leukemia (CML)
Myelodysplastic syndrome (MDS)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the safety and efficacy of HLA-haploidentical allogeneic stem cell transplantation from related donor for patients with poor-prognosis leukemia and myelodysplastic syndrome or patient with refractory leukemia and myelodysplastic syndrome lacking an HLA serological identical or a single antigen mismatched related donor who need urgent stem cell transplantation due to disease progression.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Engraftment rate
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 Fludarabine(15mg/square meter of body surface area twice a day for 2 days and 30mg/square meter once a day for 4 days), cytarabine(2g/square meter twice a day for 2 days), buslufan(0.8mg/kg 4 times a day for 4 days) and ATG(2mg/kg per day for 2days) is used as a conditioning regimen. (If a patient has a history of using Busulfan as a conditioning regimen of previous transplantation, Melphalan(100mg/ square meter per day for 1 day) is used instead of Busulfan.) Cyclophosphamide (25mg/kg)is used on day3, 4 after the graft infusion. The donor source is peripheral blood stem cell. Patients receive cotinuous intravenous tacrolimus (0.03mg/kg/day) and mycophenolate mofetil 3000mg/day from day4 after hematopoietic stem cell transplantation.
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with refractory leukemia or MDS lacking an HLA-identical or single-antigen mismatched related donor, who need an urgent allogeneic transplant but are ineligible for unrelated donor from marrow donor registry in a timely fashion due to rapid disease progression, or patients with refractory leukemia or MDS considered incurable by only conventional chemotherapy, who have no HLA-identical related or HLA-single-antigen mismatched related donor.
2) Patients without a HLA-haploidentical donor of family member or relative
3) >= 15 and <= 70 years old
4) ECOG PS 0-1
5) Normal function of major organ
6) Informed consent

7) Patients who in need of an urgent allogeneic transplant
a) De novo AML and ALL: refractory to first induction therapy or refractory to chemotherapy after relapse
b) CML in AP or BC: refractory to TKIs including imatinib, dasatinib and nilotinib
c) Secondary acute leukemia following MDS: refractory to first induction therapy
d) Patients with AML, ALL, CML or secondary acute leukemia who relapsed after allogeneic transplant and failed to achieve CR
8) Patients who have indication for allogeneic transplant due to unfavorable prognosis but lack a suitable related donor
a) Patients with de novo AML in CR with unfavorable chromosome abnormality including del(5q)/-5, -7/del(7q), abn 3q, 9q, 11q, 20q, 21q, 17q, t(6;9), t(9;22) or complex karyotype
b) Patients with de novo AML in CR with normal karyotype and FLT3-ITD mutation
c) Patients with ALL in 1CR who have following poor prognostic factors
i) t(9;22) or t(4;11)
ii) >= 35 years at diagnosis
iii) WBC count of more than 30000/uL for B- ALL, or more than 100000/uL for T-ALL at diagnosis
d) AML, ALL in CR state except for 1CR
e) CML in CR state except for 1CR
f) Secondary leukemia following MDS, or patients with RAEB-1, 2
g) Patients with AML, ALL, or secondary leukemia in CR state or CML in CP who relapsed after allogeneic transplant
Key exclusion criteria 1) Major organ dysfunction
a) Total bilirubin: >= 2.0mg/dl
b) Serum creatinine: >= 2.0mg/dl
c) Ejection fraction: < 50 %
d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air
e) AST or ALT >= 3 x UNL
2) Uncontrolled active infection
3) Uncontrolled CNS invasion
4) Poorly controlled insulin-treated diabetes mellitus
5) Poorly controlled hypertension
6) Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia
7) Pregnant, nursing or possible fertile woman
8) Patients with severe mental disorder who are likely to unable to participate in the study
9) A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplant
10) HIV antibody positivity
11) No indication for this study judged by physician in charge.
(Note: HBs antigen positivity and HCV antibody positivity is not excluded.)
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hino
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Email hinom@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Nakamae
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Homepage URL
Email crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute Hematology, Osaka City University, Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 12 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
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 Completed
Date of protocol fixation
2009 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 25 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 11 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002370

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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