Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019>

Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019> - Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma<THF019>

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008017

Enrollment

Registered

2012-05-23

Start date

2012-06-01

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

follicular lymphoma

Interventions

Rituximab combination chemotherapy 1course/3W [Maximum 6-8 course] Rituximab monotherapy 1course/8W[until 2 years] Rituximab 375 mg/m2 div day0 or day1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Follicular lymphoma[FL] [exclude patients with Histologic transformation] 2)grade 1, 2, 3a 3)no previous chemotherapy 4)CD20 positive 5)Age:18 to 74 6)Performance Status:0 to 2 7)having musurable lesion 8-1)WBC:3,000/mm3 or more Neutrophil:1,200/mm3 or more Platlets:7.5x10^4/mm3 or more 8-2)AST[GOT]/ALT[GPT]:5xnormal upper limit or less T-bil:2.0mg/dL or less 8-3)Creatinine:1.5mg/dL or less 9)Written informed consen

Exclusion criteria

Exclusion criteria: 1)active double cancer 2)severe infection or severe complication 3)having prior drug allergy 4)prior treated heart failure or renal failure 5)Cirrhosis of the liver 6)HBs-Ag positive 7)Disorder of electrocardiogram, Disorder of heart fanction, severe heart disease 8)pregnant/lactating woman 9)psychosis 10)given systemic steroid 11)Physician's decision of inappropriateness

Design outcomes

Primary

Measure	Time frame
Progression free survival at 2 years[2y PFS]	—

Secondary

Measure	Time frame
Best Response Rate, Complete Response Rate, Overall Response Rate, Overall survival, Progression Free Survival, Bcl-2 negative conversion rate, Minimal Residual Disease, Safety	—

Countries

Japan

Contacts

Public ContactEijiro Omoto

Yamagata Prefectural Central Hospital Department of Hematology

ej-omoto@vega.ocn.ne.jp023-685-2626

Outcome results

None listed

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

Clinical study to investigate the efficacy of rituximab monotherapy after the rituximab combination chemotherapy for previously untreated follicular lymphoma&lt;THF019&gt;