Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma

Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma - Fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003867

Enrollment

Registered

2010-07-05

Start date

2010-01-01

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

Indolent B cell lymphoma

Interventions

As dose limiting toxicity, delayed bone marrow recovery is selected. Delayed bone marrow recovery is defined that neutrophil count less than 1000/ mm3 or platelet count less than 50000/mm3 after 12

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (a)Have had diagnosis of indolent B cell lymphoma (b)Relapsed or refractory patients (c)The number of previous chemotherapy regimens is two or less (d)After rituximab more than 12 weeks (e)After previous chemotherapy more than 4 weeks (f)CD20 positive by flowcytometry or immunohistochemistory (g)Aged 20 - 79 (h)PS 0 - 2 (i)Without CNS involvement (j)Have measurable lesions(diameter more than 1.5cm) (k)Have adequate organs functions (l)Gave written informed consent (m)Expectet survival period more than three manths (n)Not pregnant or lactating (o)Consent to contraception

Exclusion criteria

Exclusion criteria: (a)History of hematopoietic stem cell transplantation (b)History of whole pelvic or whole abdomen radiation (c)Received G-CSF or erythropoietin or transfusion less than one week before registration (d)Taken an operation less than four weeks before registration (e)History of Zevalin therapy (f)History of the treatment of purin analogs (g)Have active systemic infections (h)Have a serious complication(cardiac dysfunction, hepatic failure, or renal failure) (i)Have a serious digestive organ symptom (j)Have a serious bleeding tendency (k) Positive for HBs antigen, HCV antibody, or HIV antibody. (l)Have an interstitial pneumonia or fibrosis (m)Active cancers (n)Have or history of autoimmune hemolytic anemia (o)Have aglucoma (p) Otherwise judged by investigator to be unsuitable

Design outcomes

Primary

Measure	Time frame
Periods from the initiation of Zevalin therapy to the time of bone marrow recovery, neutrophil count is more than 1000/mm3 and pletlet count is more than 50000/mm3.	—

Countries

Japan

Contacts

Public ContactKenichi Ishizawa

Tohoku University Graduate School of Medicine Hematology & Rheumatology

kishizaw@med.tohoku.ac.jp022-717-7165

Outcome results

None listed

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