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View Clinical Trial (Medical Research Study)
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Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma - NCT00722930-Donostia - 008 (Clinical Trial 233665)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy233665.aspx
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| City: |
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Donostia |
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Country:
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Spain |
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| Conditions: |
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Follicular Lymphoma |
| Purpose: |
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To evaluate the complete clinical response rate according to the International Working Group
criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients
with high-risk follicular lymphoma with either partial or complete response to R-CHOP
induction chemotherapy
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Signature of the written informed consent by the subject or his/her legal
representative before initiation of any trial specific procedure.
- Patients older than 18.
- Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO
classification.
- High-risk patients according to FLIPI before initiation of induction chemotherapy.
- Stage II-IV prior to initiation of induction treatment, or any stage in patients with
grade 3 follicular lymphoma.
- Complete or partial response to the induction scheme.
- ECOG scale performance status 0 - 2.
- Life expectancy greater than 3 months.
- In women of childbearing age, use of a reliable contraceptive method.
- A suitable bone marrow reserve:
- Lower than 25% Bone marrow infiltration by lymphoma.
- Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
- Suitable hepatic, renal and cardiac function:
- creatinine <2,5 x UNL (upper normality limit).
- bilirubin or ALT/AST < 2,5 x UNL
Exclusion Criteria:
- Patients with no objective clinical response to induction chemotherapy.
- > 25% bone marrow infiltration following induction chemotherapy.
- Platelets < 100,000 before radioimmunotherapy.
- Severe and/or uncontrolled concomitant disease:
- Hepatic, renal, cardiovascular, neurological or metabolic disease.
- Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of
myocardial infarction or angor, or major ventricular arrhythmia.
- Positive regarding HBV, HCV, HIV.
- Active acute or chronic infection.
- Social, psychic or geographic disability to satisfy any of the treatment schemes.
- Pregnant and/or breastfeeding women, or adult patients of childbearing age who are
not using a safe birth control device throughout the study treatment and at least 12
months thereafter.
- Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to
the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a
history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other
anthracyclines, cytarabine). |
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| Study is available at: |
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Instituto Oncológico San Sebastián
Donostia
Spain
Primary Contact:
Mariano Provencio, MD
Email: mprovenciop@yahoo.es
Phone: +34-91-344-57-60 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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