Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2008-01-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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90Y-Ibritumomab Tiuxetan double dose
90Y-Ibritumomab Tiuxetan administered at 0.4 mCi/kg at phase 2 and then at 0.2 mCi/kg at phase 3
90Y-Ibritumomab Tiuxetan
All patients receive 2 courses of age-adjusted R-miniDHAP followed by two doses of 90Y-Ibritumomab Tiuxetan
Interventions
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90Y-Ibritumomab Tiuxetan
All patients receive 2 courses of age-adjusted R-miniDHAP followed by two doses of 90Y-Ibritumomab Tiuxetan
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
3. Stage II, III, IV according to Ann Arbor criteria
4. Chemoresistant disease after first line treatment (CHOP-like + Rituximab) or relapsed patients after one or two lines of chemotherapy not-eligible for high dose chemotherapy and autologous stem cell transplantation
5. Performance status 0-2 according to WHO criteria
6. HIV negativity
7. Normal liver, lung and kidney function: conjugated bilirubin up to 2 x ULN, alkaline phosphatase and transaminases up to 2 x ULN, creatinine clearances ≥45 ml/min
8. Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 150 x 109/l and bone marrow involvement \< 25% before first Zevalin infusion.
9. Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
10. Use of effective contraception for the entire treatment period in patients sexually active
11. Negative pregnancy test in child bearing potential women
12. Life expectancy \> 6 months
13. Written informed consent
Exclusion Criteria
2. Prior high dose chemotherapy and autologous stem cell transplantation
3. HIV positivity
4. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
5. HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
6. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
7. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
8. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
9. Pregnant or breastfeeding
10. CNS lymphoma involvement.
11. History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
12. Cardiac failure with VEF \< 40%
13. Clinical evidence of not controlled infections
18 Years
75 Years
ALL
No
Sponsors
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Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
OTHER
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
OTHER
Responsible Party
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Principal Investigators
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Barbara Botto, MD
Role: STUDY_DIRECTOR
SCDO Ematologia AOU San Giovanni Battista Torino
Umberto Vitolo, MD
Role: PRINCIPAL_INVESTIGATOR
SCDO Ematologia 2 AOU San Giovanni Battista Torino
Locations
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Divisione di Ematologia Ospedale SS Antonio e Biagio
Alessandria, AL, Italy
Istituto di Ematologia e Oncologia Medica L. Seragnoli Policlinco S. Orsola
Bologna, BO, Italy
Divisione di Ematologia, Spedali Civili
Brescia, BS, Italy
Divisione di Ematologia Ospedale Centrale di Bolzano
Bolzano, BZ, Italy
Divisione di Ematologia Ospedale Businco
Cagliari, CA, Italy
Divisione di Ematologia Ospedale Cardinale Panico
Tricase, LE, Italy
Divisione di Ematologia Ospedale Niguarda Cà Granda
Milan, MI, Italy
Divisione di Oncoematologia IRCC
Candiolo, TO, Italy
Divisione di Ematologia Istituto Nazionale Fondazione Pascale
Napoli, , Italy
SC Ematologia Ospedale Maggiore Università Avogadro
Novara, , Italy
Divisione di Oncoematologia Azienda Ospedalier S. Maria
Terni, , Italy
SCDO Ematologia 2 AOU San Giovanni Battista
Turin, , Italy
Countries
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Other Identifiers
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ZETAL07
Identifier Type: -
Identifier Source: org_study_id