A phase I/II study combining mogamulizumab and lenalidomide for relapsed/refractory ATL

JRCT ID: jRCTs071180079

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult T-cell leukemia/lymphoma(ATL)
• Date of first enrollment: 04/08/2020
• Target sample size: 4
• Study type: Interventional
• Intervention(s): Lenalidomide combined with mogamulizumab

Outcome(s)

• Primary Outcome: Phase I:recommended dose, phase II:overall response rate

Secondary Outcome

Phase I:Rate of adverse event, overall response rate
Phase II:Complete response rate, overall survival time, 1 year event free survival rate, rate of adverse event, response rate by prior treatments

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 with 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

Exclude 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 control
led 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 from autologous SCT to the scheduled first day of protocol treatment
22)History of sever adverse event s (AEs) with thalidomide
23)History of dermatological AEs more than grade 3, or continuous administration of systemic adreno corticoids for the dermatological adverse events, by mogamulizumab or lenalidomide
24)Less than 4 weeks interval from the last administration of other investigational drugs to the scheduled first day of protocol treatment
25)Less than 2 weeks interval from the last administration of mogamulizumab or lenalidomide to the scheduled first day of protocol treatment
26)Less than 2 weeks interval from the last chemotherapy for ATL to the scheduled first day of protocol treatment
27)Other inadequate conditions determined by investigators

Related Information

• Primary Sponsor: Imaizumi Yoshitaka
• Secondary Sponsor: Bristol-Myers Squibb K.K.
• Secondary ID(s): UMIN000031500