UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma
Title of the study (Brief title)	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	Masayuki Hino
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology
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	Mika Nakamae
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology (Clinical center for hematological malignancies)
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 10 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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