A phase II trial of CHOP-14 with Mogamulizumab for untreated elderly patients with CCR4 positive adult T-cell leukemia/lymphoma

JRCT ID: jRCTs041180130

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult T-cell leukemia lymphoma
• Date of first enrollment: 16/11/2015
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Mogamulizumab
1mg/kg, every 2 weeks (with CHOP-14) 6+2cycles
CHOP (every 2 weeks) 6 cycles
CPA 750mg/m2 div Day 1
DXR 50mg/m2 div Day 1
VCR 1.4mg/m2 (max 2.0mg) iv Day 1
PSL 40mg/m2 po Day 1, 2, 3, 4, 5

Outcome(s)

• Primary Outcome: 1 year progression free survival

Secondary Outcome

complete response rate
response rate
overall survival
1 year event free survival
adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 56age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Those who meet all of the following are eligible.
1) Cytologically or pathologically proven peripheral T-cell malignancy with positivity for anti-HTLV-1 antibody.
2) ATL in acute type, lymphoma type, or chronic type with unfavorable prognostic factors.
3) Positive for CCR4 antigen by flow cytometry or immunehistochemistry.
4) Aged over 66 years old or between 56 and 65years old if the patients do not want to receive allogeneic stem cell transplantation.
5) ECOG PS 0-3, or PS 4 with hypercalcemia.
6) No previous anti-cancer treatment, except for interferon and antiretroviral treatment. Steroids should be discontinuation until registration.
7) Meet all of the following
i) neutrophil=>1,500/mm3
(neu=>500/mm3 with bone marrow involvement)
ii) Platelet=>10.0x104/mm3
(PLT 2.0x104/mm3 with bone marrow involvement)
iii) GOT(AST)=>150 U/L
(GOT(AST)=<300 U/L with Liver involvement)
iv) male : GPT(ALT)=<210 U/L
female : GPT(ALT)=<115 U/L
(male : GPT(ALT)=<420 U/L, female : GPT(ALT)=<230 U/L with liver involvemnet)
v) T.Bil=<2.0mg/dL (T.Bil=<5.0mg/dL with liver involvement)
vi) serum creatinine=<1.6mg/dL(male), 1.2mg/dL (female)
vii) SpO2=>92% (room air)
(SpO2=>90% (room air) with lung involvement)
viii) Normal ECG
ix) Ejection fraction=>50% by UCG
8) Written informed consent.

Exclude criteria

1) CNS disease
2) Complication of coronary disease, cardiomyopathy, cardiac failure, or arrhythmia requiring medical
intervention.
3) Diabetes mellitus uncontrolled by administration of insulin
4) HBs-Ag positive
5) HCV-Ab positive
6) HIV-Ab positive
7) Liver cirrhosis
8) Complication of interstitial pneumonia or pulmonary fibrosis requiring oxygen administration
9) Synchronous or metachronous malignancy
10) Autoimmune disease
11) Pregnant or lactating women
12) Psychiatric disease
13) History of hypersensitivity to any of the components of the formulation in POTELIGEO.
14) Patients who are considered to be unsuitable for enrollment by the physician.

Related Information

• Primary Sponsor: Ishitsuka Kenji
• Source(s) of Monetary Support: Kyowa Kirin Co., Ltd.
• Secondary ID(s): UMIN000019357