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Zevalin® First Line in Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT00772655
Recruitment Status : Unknown
Verified July 2012 by Christian Scholz M.D., Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2008
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Christian Scholz M.D., Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE October 14, 2008
First Posted Date  ICMJE October 15, 2008
Last Update Posted Date August 2, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan [ Time Frame: 6 months from entry onto trial ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
  • Time to progression after treatment with 90Y-Ibritumomab Tiuxetan [ Time Frame: 5 years from entry onto trial ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zevalin® First Line in Follicular Lymphoma
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • 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:
    • Zevalin®
    • Mabthera®
  • 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®
Study Arms  ICMJE 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.
Interventions:
  • Drug: 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab
  • Drug: Rituximab
Publications * Scholz CW, Pinto A, Linkesch W, Lindén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00772655
Other Study ID Numbers  ICMJE EudraCT-No.:2006-005778-34
PEI-No.: 364/01
BFS-No.: 22461/2-2007-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Scholz M.D., Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Pezzutto, Prof. Dept. of Hematology, Charité Berlin, Germany
Study Director: Christian Scholz, PD Dept. of Hematology, Charité Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP