A PHASE II, OPEN-LABEL, PROSPECTIVE, MULTICENTER STUDYTO EVALUATE THE EFFICACY AND SAFETY OF SUBSEQUENTTREATMENT WITH THE ZEVALIN (IBRITUMOMAB TIUXETAN)IN ELDERLY ( 60 YEARS) PATIENTS WITH DIFFUSE LARGE BCELLLYMPHOMA AFTER 4 CYCLES OF CHOP21 ?RITUXIMAB(CHOP21-R) THERAPY. - ND
- Conditions
- DIFFUSE LARGE BCELLLYMPHOMAMedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma
- Registration Number
- EUCTR2006-004851-39-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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 nonresponder
according to the International Workshop Response Criteria for NHL described by Cheson
et al (18) afterfour 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) ? 1.5 x 109/L within 1 week of accrual;
8. Hemoglobin (Hgb) ? 10 g/dL within 1 week of accrual;
9. Platelets. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 anduncontrolled 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method