Sequential combination therapy with CHOP and mogamulizumab in untreated primary ATLL patients

JRCT ID: jRCTs071180057

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: adult T-cell leukemia-lymphoma
• Date of first enrollment: 27/10/2016
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Mogamulizumab is administered 8 times at the dose of 1mg/kg in every 2 weeks after 3 courses of CHOP-21 chemotherapy.

Outcome(s)

• Primary Outcome: Overall Survival (OS)

Secondary Outcome

1. Progression-free survival (PFS) at 1 year point after initial treatment
2. Overall survival (OS) at 1 year point after initial treatment
3. Overall response rate (ORR)
4. ORR according to lesion
5. Complete response rate
6. Evaluation of safety: occurrence of adverse events

Key inclusion & exclusion criteria

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

Include criteria

1) Patients with untreated primary ATL nonadaptive for transplantation (diagnosed by HTLV-1 antibody positive, hemocytologically/ histopathologically and surface character)
2) Patients with serum anti HTLV-1 antibody positive.
3) Patients with any of acute type, lymphoma type or chronic type with prognosis decision factor in ATL disease type categories.
4) Patients with more than 20 years old at the enrollment date.
5) Patients with performance status (ECOG) 0 - 2.
6) Patients with measurable lesion in Response Evaluation criteria of ATL (JCOG version).
7) Patients have met the following all latest clinical test standards within 14 days prior to enrollment (eligible on the same day of the last week of the enrollment day)
(1) Serum creatinine: < 2.0mg/dL (eligible in the case of neoplastic increase)
(2) AST, ALT, ALP: < 2.5 times of upper limit of normal.
(3) Total bilirubin < 2.0mg/dL
8) Patients providing the written informed consent.

Exclude criteria

1) Patients with uncontrollable diabetes mellitus.
2) Patients with uncontrollable hypertension.
3) Patients with uncontrollable autoimmune disease.
4) Patients with severe skin disorder other than ATL lesion.
5) Patients with anamnesis of myocardial infarction and congestive heart failure, and complication of unstable angina.
6) Patients with less than 50% of resting ejection fraction in echocardiography and nuclear medical scan.
7) Patients with active double cancer.
8) Patients with uncontrollable active infection.
9) Patients with central nervous infiltration.
10) Patients with HIV antibody positive or HBs antigen positive.
11) Patients with complication of mental disease or psychiatric symptom.
12) Patients with pregnancy or possibility of pregnancy and patients with nursing.
13) Patients judged by the investigator to be inappropriate for study participation.

Related Information

• Primary Sponsor: Kato Koji
• Source(s) of Monetary Support: Kyowa Kirin Co.,Ltd.
• Secondary ID(s): UMIN000022819