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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2007-10-31
2015-06-30
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Therapy
Induction therapy with a single course of 90Yttrium-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111Indium-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 up to a maximal dose of 12.000 MBq \[if platelets are below 150000/µl only 11 MBq/kg are administered). Observation for patients achieving complete clinical and molecular response or partial clinical response. Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2 (t14;18)-positivity 6 months after 90Y-Ibritumomab Tiuxetan.
90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab
A single course of 90Y-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111In-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 \[if platelets are below 150000/µl only 11 MBq/kg are administered).
Rituximab
Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2-positivity 6 months after 90Y-Ibritumomab Tiuxetan.
Interventions
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90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab
A single course of 90Y-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111In-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 \[if platelets are below 150000/µl only 11 MBq/kg are administered).
Rituximab
Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2-positivity 6 months after 90Y-Ibritumomab Tiuxetan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Follicular lymphoma grade I, II, or IIIa according to REAL/WHO classification
* Ann Arbor stage III, or IV, or stage II with disseminated abdominal disease requiring extensive abdominal irradiation
* No prior chemotherapy, immunotherapy, or irradiation. Furthermore, when receiving therapy as part of this "Zevalin® first line in follicular lymphoma" trial and up to six months after therapy has ended, patients may not participate in another clinical trial. If patients receive consolidation therapy with Rituximab, the six months period is counted from the end of the consolidation therapy.
* Lymphoma cells positive for CD20
* Measurable disease (two perpendicular diameters by either physical or radiological examination)
* WHO/ECOG performance status 0 - 2
* Written informed consent
Exclusion Criteria
* Bone marrow infiltration \> 25%
* Leukocytopenia \< 2.500 /µl
* Thrombocytopenia \< 100.000 /µl
* Bulk lesions \> 10 cm
* CNS lymphoma manifestation
* Circulating tumor cells \> 500 /µl
* Extensive pleural effusion/ascites (\> 1000 ml as estimated by ultrasound/CT)
* Severe concomitant diseases (e.g. congestive heart failure, myocardial infarction within 6 months of study, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease, liver disease)
* Abnormal liver function: transaminases or total bilirubin \> 2 x upper limit of normal (ULN) (unless caused by the lymphoma)
* Abnormal renal function: serum creatinine \> 2 x upper limit of normal (unless caused by the lymphoma)
* Previous malignancy other than non-melanoma skin cancer
* Pregnant or breast feeding female patients (negative pregnancy test required for women of fertile age), no effective contraception
* HIV positivity
* Known hypersensitivity to foreign proteins, murine antibodies, presence of human anti-murine antibodies (HAMA) reactivity
* Severe psychiatric illness
50 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Christian Scholz M.D.
PD Dr. med. Christian Scholz
Principal Investigators
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Antonio Pezzutto, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Hematology, Charité Berlin, Germany
Christian Scholz, PD
Role: STUDY_DIRECTOR
Dept. of Hematology, Charité Berlin, Germany
Countries
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References
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Rieger K, De Filippi R, Linden O, Viardot A, Hess G, Lerch K, Neumeister P, Stroux A, Peuker CA, Pezzutto A, Pinto A, Keller U, Scholz CW. 90-yttrium-ibritumomab tiuxetan as first-line treatment for follicular lymphoma: updated efficacy and safety results at an extended median follow-up of 9.6 years. Ann Hematol. 2022 Apr;101(4):781-788. doi: 10.1007/s00277-022-04781-3. Epub 2022 Feb 12.
Scholz CW, Pinto A, Linkesch W, Linden O, Viardot A, Keller U, Hess G, Lastoria S, Lerch K, Frigeri F, Arcamone M, Stroux A, Frericks B, Pott C, Pezzutto A. (90)Yttrium-ibritumomab-tiuxetan as first-line treatment for follicular lymphoma: 30 months of follow-up data from an international multicenter phase II clinical trial. J Clin Oncol. 2013 Jan 20;31(3):308-13. doi: 10.1200/JCO.2011.41.1553. Epub 2012 Dec 10.
Other Identifiers
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PEI-No.: 364/01
Identifier Type: -
Identifier Source: secondary_id
BFS-No.: 22461/2-2007-001
Identifier Type: -
Identifier Source: secondary_id
EudraCT-No.:2006-005778-34
Identifier Type: -
Identifier Source: org_study_id