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

Phase 2

• Conditions: adult T-cell leukemia-lymphoma

• Registration Number: JPRN-jRCTs071180057
• Lead Sponsor: Kato Koji

Brief Summary

A multicenter, single-arm study was conducted to investigate efficacy and safety on sequential combination of mogamulizumab after CHOP in patients with untreated primary adult T cell leukemia-lymphoma (ATL). The primary endpoint was the overall survival. The full analysis set was 24. The median survival time (80% CI) was 12.1 (5.0 - 21.0)months, and it was not statistically significant at the one-sided 0.10 level.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2021-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified