Clinical study to investigate the efficacy and the safety of R-FM for recurrent or refractory indolent B-cell lymphoma - THF016

Clinical study to investigate the efficacy and the safety of R-FM for recurrent or refractory indolent B-cell lymphoma - THF016 - R-FM for recurrent or refractory indolent B-cell lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005442

Enrollment

Registered

2011-06-01

Start date

2011-05-01

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

recurrent or refractory indolent B-cell lymphoma

Interventions

R-FM 1course/4W (Maximum 6 course) -Rituximab 375 mg/m2 div day0 or day1 -Mitoxantrone 10 mg/m2 div day1 -Fludarabine 40 mg/m2 po day1, day2, day3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Indolent B-cell lymphoma (FL, MALT, MZL) (exclude patients with histologic transformation) 2) having prior chemotherapy 3) CD20 positive 4) Age: 18 to 74 5) Performance Status: 0 to 2 6) having measurable lesion 7-1) WBC: 3,000/mm3 or more Neutrophil: 1,200/mm3 or more Platelets: 75,000/mm3 or more 7-2) AST (GOT)/ALT (GPT): 5xnormal upper limit or less T-bil: 2.0mg/dL or less 7-3) Creatinine: 1.5mg/dL or less 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) active double cancer 2) severe infection or severe complication 3) having more than 300mg/m2 of Doxorubicin 4) having prior Zevarin 5) having prior purine analog 6) having prior drug allergy 7) prior treated heart failure or renal failure 8) Cirrhosis of the liver 9) HBs-Ag positive 10) Disorder of electrocardiogram, Disorder of heart fanction, severe heart disease 11) pregnant/lactating woman 12) psychosis 13) given systemic steroid 14) Physician's decision of inappropriateness

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Best Response rate, Complete Response rate, Survival time (Overall survival, Median survival time, 2-year-survival rate etc.), Time to progression, Bcl-2 negative conversion rate, Safety	—

Countries

Japan

Contacts

Public ContactTakenori Takahata

Hirosaki University Graduate School of Medicine Division of Medical Oncology

takatake@cc.hirosaki-u.ac.jp+81-172-39-5346

Outcome results

None listed

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