UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002606 |
|---|---|
| Receipt number | 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 15:52:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
crc-hematology@med.osaka-cu.ac.jp
Sponsor or person
Institute
Hematology, Osaka City University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003054
