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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002606
Receipt No. R000003054
Scientific Title HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma
Date of disclosure of the study information 2009/10/10
Last modified on 2018/10/31

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Basic information
Public title HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma
Acronym HLA-haploidentical allogeneic stem cell transplantation for ATL/L and refractory aggressive lymphoma
Scientific Title HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma
Scientific Title:Acronym HLA-haploidentical allogeneic stem cell transplantation for ATL/L and refractory aggressive lymphoma
Region
Japan

Condition
Condition Adult T-cell leukemia/lymphoma (acute type and lymphoma type)
Malignant lymphoma
(aggressive hodgkin and non-hodgkin lymphoma)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess safety and efficacy of HLA-haploidentical allogeneic stem cell transplantation from related donor for patients with ATL/L or refractory agressive lymphoma who have indication for allogeneic transplant but lacking an HLA-serological identical or a single antigen mismatched donor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

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), Melphalan (100mg/ square meter per day for 1 day) is used as a conditioning regimen. Cyclophosphamide (25 mg/kg) is given on day 3, 4 after the graft infusion. The donor source is peripheral blood stem cell. Continuous intravenous tacrolimus (0.03mg/kg/day) and oral mycophenolate mofetil 3,000mg/day are initiated from day 5 after 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 ATL/L or refractory malignant lymphoma lacking an HLA-identical or single-antigen mismatched related donor.
2) Patients without a HLA-haploidentical donor of family member or relative
3) >= 15 and < 70 years old
4) PS 0-1
5) Normal function of major organ
6) Informed consent
7) ATL/L or malignant lymphoma
a) ATL/L: Acute or lymphoma type, PR or better
b) Malignant lymphomas in WHO classification 2008 as shown below which relapsed after autologous HSCT, or which have no indication for autologous HSCT due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy.
Mature B-cell neoplasms
B-cell PLL
MCL
FL transformed
Advanced FL: refractory to Rituximab and chemotherapy
DLBCL, NOS(except Primary DLBCL of the CNS)
DLBL associated with chronic inflamation
Primary mediastinal large B-cell lymphoma
ALK+ large B-cell lymphoma
Plasmablastic lymphoma
Intravascular large-B cell lymphoma (IVL)
Large B-cell lymphoma arising in HHV8-associated multicentric Castlemann disease
Primary effusion lymphoma
Burkitt lymphoma
B-cell lymphoma unclassible
Mature T cell and NK-cell neoplasms
T-cell PLL
T-cell large granular lymphocytic leukaemia
Aggressive NK-cell leukemia
Extranodal NK/T-cell lymphoma, nasal type
Enteropathy-associated T-cell lymphoma
Hepatosplenic T-cell lymphoma
Subcutaneous panniculitis-like T-cell lymphoma
Primary cutaneous gamma-delta T-cell lymphoma
Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
Peripheral T-cell lymphoma NOS
Angioimunoblastic T-cell lymphoma
Anaplastic large cell lymphoma, ALK+ or ALK-
Hodgkin lymphoma
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 mental disorder or neurological 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) Patients with history of administration of mogamulizumab
12) 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 (Clinical center for hematological malignancies)
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 10 Month 10 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 Terminated
Date of protocol fixation
2009 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 09 Day
Last follow-up date
2014 Year 09 Month 01 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 10 Month 08 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003054

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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