UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031500 |
|---|---|
| Receipt number | 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 | 2022/03/03 10:04:10 |
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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
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
y-imaizm@nagasaki-u.ac.jp
Sponsor or person
Institute
Nonprofit Organization, Clinical Hematology Oncology Treatment Study Group
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
transfered to jRCT(jRCTs071180079)
Management information
Registered date
| 2018 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035865
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