NCT00902525TerminatedPhase 2
Two Repeated Doses of Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) as Salvage Treatment for Patients With Relapsed or Refractory Aggressive B-cell Lymphoma: a Phase II Study.
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie12 sites in 1 country25 target enrollmentStarted: January 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 25
- Locations
- 12
- Primary Endpoint
- An interim analysis on all the available data after the enrolment of the 15th patient (completion of the 1st stage) will be conducted, both for safety and efficacy.
Study Overview
Brief Summary
Despite of the availability of treatment for this disease, this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the clinical outcome and prognosis of relapsed aggressive lymphoma. This study is designed for patients not eligible for high-dose chemotherapy and autologous stem cells transplantation.
Detailed Description
The objectives of this study are to evaluate the efficacy and safety of two sequential doses of 90Y-Ibritumomab Tiuxetan administered after salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma non-eligible for HDC and ASCT.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
- •Stage II, III, IV according to Ann Arbor criteria
- •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
- •Performance status 0-2 according to WHO criteria
- •HIV negativity
- •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
- •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.
- •Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
- •Use of effective contraception for the entire treatment period in patients sexually active
- •Negative pregnancy test in child bearing potential women
- •Life expectancy > 6 months
- •Written informed consent
Exclusion Criteria
- •More than two lines of prior chemotherapy before study entry
- •Prior high dose chemotherapy and autologous stem cell transplantation
- •HIV positivity
- •HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- •HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- •History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- •Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
- •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
- •Pregnant or breastfeeding
- •CNS lymphoma involvement.
- •History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
- •Cardiac failure with VEF < 40%
- •Clinical evidence of not controlled infections
Arms & Interventions
90Y-Ibritumomab Tiuxetan double dose
Experimental
90Y-Ibritumomab Tiuxetan administered at 0.4 mCi/kg at phase 2 and then at 0.2 mCi/kg at phase 3
Intervention: 90Y-Ibritumomab Tiuxetan (Drug)
Outcomes
Primary Outcomes
An interim analysis on all the available data after the enrolment of the 15th patient (completion of the 1st stage) will be conducted, both for safety and efficacy.
Time Frame: after the enrolment of the 15th patient
Secondary Outcomes
- after the interim analysis, the writing committee of the study will evaluate to increase the second dose of Zevalin to 0.3 mCi/Kg. The same procedure will be applied to decide if the trial must be stopped after the enrolment of the 23rd patient.(after the enrolment of the 23rd patient)
Investigators
Study Sites (12)
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