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

Phase 1
Conditions
Indolent B cell lymphoma
Registration Number
JPRN-UMIN000003867
Lead Sponsor
Tohoku Hematology Form
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
12
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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