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

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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 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


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

Value
https://center6.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