Zevalin® First Line in Follicular Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Christian Scholz M.D., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00772655
First received: October 14, 2008
Last updated: July 31, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). For patients with complete clinical remission but persistent molecular disease subsequent to 90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to eradicate minimal residual disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma |
Drug: 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter European Pilot Study of 90Yttrium-Ibritumomab Tiuxetan as First Line Therapy for Stage III - IV Follicular Lymphoma (and Selected Patients With Extended Stage II) Followed by Consolidation Rituximab for Patients in Complete Remission But With Persistent Molecular Disease |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan [ Time Frame: 6 months from entry onto trial ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to progression after treatment with 90Y-Ibritumomab Tiuxetan [ Time Frame: 5 years from entry onto trial ] [ Designated as safety issue: No ]
- Ability of consolidation therapy with Rituximab to induce molecular remission for CR patients not achieving molecular remission within 6 months after 90Y-Ibritumomab Tiuxetan [ Time Frame: 5 years from entry onto trial ] [ Designated as safety issue: No ]
- Safety and tolerability of 90Y-Ibritumomab Tiuxetan with particular respect to further therapy strategies in relapsed patients [ Time Frame: 5 years from entry onto trial ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | June 2015 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: 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).
Other Names:
Drug: 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 Name: Mabthera®
|
Detailed Description:
Only patients requiring treatment (B-symptoms, lymphoma progression > 50% within an observation period of 6 months or less, organ compression by lymphoma or bulky disease as defined by lesions above 5 cm on one axis) may enter the study.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient > 50 years old
- 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 involvement only
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772655
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Antonio Pezzutto, Prof. | Dept. of Hematology, Charité Berlin, Germany |
| Study Director: | Christian Scholz, PD | Dept. of Hematology, Charité Berlin, Germany |
More Information
No publications provided by Charite University, Berlin, Germany
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Christian Scholz M.D., PD Dr. med. Christian Scholz, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00772655 History of Changes |
| Other Study ID Numbers: | EudraCT-No.:2006-005778-34, PEI-No.: 364/01, BFS-No.: 22461/2-2007-001 |
| Study First Received: | October 14, 2008 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
Follicular Lymphoma First line therapy Zevalin 90Yttrium-Ibritumomab Tiuxetan |
Yttrium Rituximab Radio-immuno therapy |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Rituximab Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013