Clareo Health | Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) in Elderly (More Than 60 Years) Patients With Diffuse Large B Cell Lymphoma After 4 Cycles of CHOP21-Rituximab (CHOP21-R) Therapy
Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) in Elderly (More Than 60 Years) Patients With Diffuse Large B Cell Lymphoma After 4 Cycles of CHOP21-Rituximab (CHOP21-R) Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Bologna
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP21-R therapy);
2. Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence/evidence with an infiltration \<25% of DLBCL in bone marrow;
3. The first part of the treatment of DLBCL must have been 4 cycles of standard CHOP21 chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and at least 40 mg/m2/day prednisone on Days 1 to 5 every three weeks) in combination with rituximab (375 mg/m2);
4. Complete remission (CR), unconfirmed complete remission (CRu), partial response, and non-responder according to the International Workshop Response Criteria for NHL described by Cheson et al (18) after four cycles of CHOP21-R. CT scans of the neck, thorax, abdomen, and pelvis and PET total body must have been performed within 3 weeks after the last dose of the last course of CHOP21-R;
5. Patients 60-years-of-age or older at time of accrual;
6. WHO performance status (PS) of 0 to 2 within 1 week of accrual;
7. Absolute neutrophil count (ANC) more than 1.5 x 109/L within 1 week of accrual;
8. Hemoglobin (Hgb) more than 10 g/dL within 1 week of accrual;
9. Platelets more or equal than 150 x 109/L within 1 week of accrual.
10. Life expectancy of 3 months or longer
11. Written informed consent obtained according to local guidelines
You may not be if
1. Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma;
2. Prior radioimmunotherapy, radiation therapy, or any other NHL therapy;
3. Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis;
4. Histological transformation of low-grade NHL;
5. Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg);
6. Known history of HIV infection;
7. Abnormal liver function: total bilirubin \> 1.5 x ULN or ALT \> 2.5 x ULN within 1 week of accrual;
8. Abnormal renal function: serum creatinine \> 2.0 x ULN within 1 week of accrual;
9. Nonrecovery from the toxic effects of CHOP21-R therapy;
10. Known hypersensitivity to murine or chimeric antibodies or proteins;
11. G-CSF or GM-CSF therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling;
12. Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study;
13. Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy;
14. Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery;
15. Concurrent corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment;
16. Unwillingness or inability to comply with the protocol.
