Status:
COMPLETED
Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
Bayer
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR ...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed CD20 +ve follicular lymphoma grades I to IIIa.
- Patients with at least one of the following symptoms requiring initiation of treatment: (as outlined by the modified BNLI/GELF criteria below)
- Nodal mass \> 7cm in its greater diameter
- B symptoms
- Elevated serum LDH or beta2-microglobulin
- involvement of at least 3 nodal sites (each with a diameter \> 3 cm)
- symptomatic splenic enlargement
- compressive syndrome
- Patients must have an ECOG performance status less than or equal to 2 and an anticipated survival of at least 6 months.
- Patients must have an absolute granulocyte count of above 1,500/mm3, and a platelet count of above 100,000/mm3 post 4 weeks of unlabelled Rituximab. A hemoglobin \>= 8.0 g/dl
- Patients must have adequate renal function (defined as calculated creatinine clearance \> 30 ml/mn), hepatic function (defined as total bilirubin \<1.5 times upper limit of normal), and hepatic transaminases (defined as AST \<5 times upper limit of normal)
- Patients must have given informed consent prior to study entry.
Exclusion
- Patients with a mean of \>20% of the intratrabecular marrow space involved with lymphoma on bone marrow biopsy following induction Rituximab therapy.
- Transformed follicular lymphoma and discordant lymphoma
- Patients with active obstructive hydronephrosis.
- Patients with initial disease bulk greater than 10cm.
- Patients with evidence of active infection requiring i.v. antibiotics at the time of study entry.
- Patients with congestive heart failure stage III or IV of NYHA classification, myocardial infraction or unstable angina within 6 months or other serious illness that would preclude evaluation.
- Patients with left VEF \< 40%
- Patients with large pleural or peritoneal effusions.
- Patients with known HIV infection or active HBV (HbsAg positivity) or HCV infection.
- Known Hypersensitivity to murine antibodies or proteins
- Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following 90Y-ibritumomab tiuxetan antibody therapy.
- Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years.
Key Trial Info
Start Date :
June 6 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01493479
Start Date
June 6 2007
End Date
November 6 2015
Last Update
October 15 2019
Active Locations (7)
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1
Centre Hospitalier Universitaire de Lille
Lille, France
2
Centre Hospitalier Universitaire de Nantes
Nantes, France
3
Centre Henri Becquerel
Rouen, France
4
St George's Hospital
London, United Kingdom