Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16)

Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16) - FBMTG MOG16

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022819

Enrollment

Registered

2016-06-21

Start date

2016-10-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult T-cell leukemia-lymphoma

Interventions

Mogamulizumab is administered 8 times at the dose of 1mg/kg in every 2 weeks after 3 courses of CHOP-21 chemotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKoji Kato

Kyushu University Hospital Department of Hematology and Oncology

kojikato@intmed1.med.kyushu-u.ac.jp092-642-5230

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026