Zevalin® First Line in Follicular Lymphoma

July 31, 2012 updated by: Christian Scholz M.D., Charite University, Berlin, Germany

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • 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 Names:
  • Mabthera®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan
Time Frame: 6 months from entry onto trial
6 months from entry onto trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression after treatment with 90Y-Ibritumomab Tiuxetan
Time Frame: 5 years from entry onto trial
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
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
5 years from entry onto trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (ESTIMATE)

October 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT-No.:2006-005778-34
  • PEI-No.: 364/01
  • BFS-No.: 22461/2-2007-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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