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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031500
Receipt No. R000035865
Scientific Title A phase I/II study combining mogamulizumab and lenalidomide for CCR4 positive relapsed/refractory aggressive adult T-cell leukemia/lymphoma
Date of disclosure of the study information 2018/02/27
Last modified on 2018/02/27

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Basic information
Public title A phase I/II study combining mogamulizumab and lenalidomide for CCR4 positive relapsed/refractory aggressive adult T-cell leukemia/lymphoma
Acronym A phase I/II study combining mogamulizumab and lenalidomide for relapsed/refractory ATL
Scientific Title A phase I/II study combining mogamulizumab and lenalidomide for CCR4 positive relapsed/refractory aggressive adult T-cell leukemia/lymphoma
Scientific Title:Acronym A phase I/II study combining mogamulizumab and lenalidomide for relapsed/refractory ATL
Region
Japan

Condition
Condition Adult T-cell Leukemia/Lymphoma (ATL)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficacy and safety of Lenalidomide combined with Mogamulizumab for patients with CCR4 positive, relapsed or refractory aggressive ATL (acute, lymphoma, and chronic type with unfavorable prognostic factors).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes P1 portion; determining the recommended dose to combine lenalidomide with mogamulizumab

P2 portion; response rate (best overall response)
Key secondary outcomes P1 portion; toxicity, response rate

P2 portion; complete response rate, overall survival, progression free survival, toxicity, response rate according to prior therapies

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 Phase 1 portion;
Mogamulizumab plus lenalidomide induction: 1 mg/m2 of mogamulizumab 8 times bi-weekly (fixed dose and schedule) with 5 to 25 mg/day of oral lenalidomide.

Phase 2 portion;
Induction by mogamulizumab and lenalidomide;
1 mg/m2 of mogamulizumab 8 times bi-weekly with recommended dose of oral lenalidomide determined in P1 portion.

Lenalidomide maintenance
Final dose of oral lenalidomide at the end of induction phase, will be continued until disease progression or intolerable adverse event.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Phase 1 portion;
1)Hematocytologically or pathohistologically proven peripheral lymphoid malignancy with T cell phenotype with positivity of anti-HTLV-1 antibody
2)Aggressive subtypes (acute, lymphoma type, or chronic type with unfavorable factor) at initial treatment
3)Positivity for CCR4 by flow cytometry or immunohistochemistry
4)Relapsed or refractory ATL after one or more prior lines of chemotherapy
5)Aged 20 or older
6)Having at least one of a measurable lesion, or an evaluable lesion in either of peripheral blood or skin
7)Women who can possibly become pregnant must agree to undergo a pregnancy test, and use birth control methods from 28 days of the first day of protocol treatment, to 28 days from the last dose of the study drug
8)Male must agree to the use of contraceptions during the protocol treatment, and for 28 days from the last dose of the study drug
9)Able to comply RevMate
10)ECOG performance status 0-3, however PS4 due to hypercalcemia is permissible
11)Adequate organ functions
(1)Neutorphil more than 1,200/mm3
(2)Platelet more than 7.5x104/mm3
(3)GOT(AST) less than 150U/L
(4)Male:GPT(ALT) less than 210U/L, Female:GPT(ALT) less than 115U/L
(5)Total Bilirubin less than 2.25mg/dL
(6)Creatinine clearance(CLCr) more than 60mL/min
(7)SpO2 more than 92%(room air)
(8)No ischemic change, atrial fibrillation, ventricular arrhythmias requiring treatment, in ECG
(9)Left ventricular ejection fraction more than 50% with echocardiography
12)Written informed consent from the patient
13)Expected more than 3 months of survival

Phase 2 portion;
1)Fulfill the inclusion criteria of phase I, except for specified below
2)CLCr more than 30mL/min
3)Criteria is modified in case of affected by ATL infiltration
(1)Neutorphil; more than 750/mm3 in case of bone marrow involvement
(2)Platelet; more than 5.0x104/mm3 in case of bone marrow involvement
(3)Total Bilirubin; less than 4.5mg/dL in case of liver involvement
(4)SpO2; more than 90% in case of pulmonary involvement
Key exclusion criteria 1)Complication of central nervous invasion
2)Unstable angina, myocardial infarction, cardiomyopathy, heart failure, or arrythmia needed treatment
3)Poorly controlled hypertension
4)Diabetes mellitus poorly controlled and regularly treated by insulin.
5)HBs-Ag positive, or HBs-Ab and/or HBc-Ab positive with HBV-DNA positive
6)HCV-Ab positive
7)HIV-Ab positive
8)Complication or history of liver chirrosis
9)Complication or history of interstitial pneumonia or pulmonary fibrosis diagnosed by image and/or symptoms, requirement of oxygen administration
10)Synchronous or metachronous malignancy except carcinoma in situ or cancer confined to the mucosa and curatively treated by local resection
11)Complication or history of autoimmune diseases
12)Complication of grade 3 peripheral neuropathy
13)High risk of thrombosis, and not accept for the prevention of venous thrombosis
14)Active infection requiring systemic treatment
15)Pregnant or nursing women
16)Psychological disturbance
17)Hypersensitivity for the component of mogamulizumab
18)History of allogeneic stem cell transplantation (SCT)
19)History of organ transplant
20)History of chemotherapy or radiotherapy for malignancy other than ATL
21)Less than 12 weeks interval form autologous SCT to the scheduled first day of protocol treatment
22)History of sever adverse events (AEs) with thalidomide
23)History of dermatological AEs more than grade 3, or continuous administration of systemic adrenocorticoids for the dermatological adverse events, by mogamulizumab or lenalidomide
24)Less than 4 weeks interval form the last administration of other investigational drugs to the scheduled first day of protocol treatment
25)Less than 2 weeks interval form the last administration of mogamulizumab or lenalidomide to the scheduled first day of protocol treatment
26)Less than 2 weeks interval form the last chemotherapy for ATL to the scheduled first day of protocol treatment
27)Other inadequate conditions determined by investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Ishitsuka, M.D., Ph.D.
Organization Kagoshima University Hospital
Division name Department of Hematology and Immunology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan
TEL 099-275-5934
Email kenji-i@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Imaizumi, M.D., Ph.D.
Organization Nagasaki University Hospital
Division name Department of Hematology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7380
Homepage URL
Email y-imaizm@nagasaki-u.ac.jp

Sponsor
Institute Nonprofit Organization, Clinical Hematology Oncology Treatment Study Group
Institute
Department

Funding Source
Organization Celgene. KK
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2018 Year 02 Month 27 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035865

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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