Know Cancer

or
forgot password

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


Phase 2
50 Years
N/A
Open (Enrolling)
Both
Follicular Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan

Outcome Time Frame:

6 months from entry onto trial

Safety Issue:

No

Principal Investigator

Antonio Pezzutto, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Hematology, Charité Berlin, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EudraCT-No.:2006-005778-34

NCT ID:

NCT00772655

Start Date:

October 2007

Completion Date:

June 2015

Related Keywords:

  • Follicular Lymphoma
  • Follicular Lymphoma
  • First line therapy
  • Zevalin
  • 90Yttrium-Ibritumomab Tiuxetan
  • Yttrium
  • Rituximab
  • Radio-immuno therapy
  • Lymphoma
  • Lymphoma, Follicular

Name

Location