Zevalin Twice in Aggressive Non-Hodgkin Lymphoma

NCT00902525 | Terminated Phase 2 DMC

• 1 other identifier: ZETAL07
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 12

Brief Summary

Despite of the availability of treatment for this disease, this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the clinical outcome and prognosis of relapsed aggressive lymphoma. This study is designed for patients not eligible for high-dose chemotherapy and autologous stem cells transplantation.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

two sequential doses of 90Y-Ibritumomab Tiuxetan

Outcome Measures

Primary Outcomes (1)

• An interim analysis on all the available data after the enrolment of the 15th patient (completion of the 1st stage) will be conducted, both for safety and efficacy.

  after the enrolment of the 15th patient

Secondary Outcomes (1)

• after the interim analysis, the writing committee of the study will evaluate to increase the second dose of Zevalin to 0.3 mCi/Kg. The same procedure will be applied to decide if the trial must be stopped after the enrolment of the 23rd patient.

  after the enrolment of the 23rd patient

Study Arms (1)

90Y-Ibritumomab Tiuxetan double dose

EXPERIMENTAL

90Y-Ibritumomab Tiuxetan administered at 0.4 mCi/kg at phase 2 and then at 0.2 mCi/kg at phase 3

Drug: 90Y-Ibritumomab Tiuxetan

Interventions

90Y-Ibritumomab Tiuxetan DRUG

All patients receive 2 courses of age-adjusted R-miniDHAP followed by two doses of 90Y-Ibritumomab Tiuxetan

90Y-Ibritumomab Tiuxetan double dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
• Stage II, III, IV according to Ann Arbor criteria
• Chemoresistant disease after first line treatment (CHOP-like + Rituximab) or relapsed patients after one or two lines of chemotherapy not-eligible for high dose chemotherapy and autologous stem cell transplantation
• Performance status 0-2 according to WHO criteria
• HIV negativity
• Normal liver, lung and kidney function: conjugated bilirubin up to 2 x ULN, alkaline phosphatase and transaminases up to 2 x ULN, creatinine clearances ≥45 ml/min
• Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 150 x 109/l and bone marrow involvement \< 25% before first Zevalin infusion.
• Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
• Use of effective contraception for the entire treatment period in patients sexually active
• Negative pregnancy test in child bearing potential women
• Life expectancy \> 6 months
• Written informed consent

You may not qualify if:

• More than two lines of prior chemotherapy before study entry
• Prior high dose chemotherapy and autologous stem cell transplantation
• HIV positivity
• HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
• HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
• History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
• Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
• Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
• Pregnant or breastfeeding
• CNS lymphoma involvement.
• History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
• Cardiac failure with VEF \< 40%
• Clinical evidence of not controlled infections

Sponsors & Collaborators

• Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie: lead
• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: collaborator

Study Sites (12)

Divisione di Ematologia Ospedale SS Antonio e Biagio

Alessandria, AL, 15100, Italy

Location

Istituto di Ematologia e Oncologia Medica L. Seragnoli Policlinco S. Orsola

Bologna, BO, 40138, Italy

Location

Divisione di Ematologia, Spedali Civili

Brescia, BS, 25100, Italy

Location

Divisione di Ematologia Ospedale Centrale di Bolzano

Bolzano, BZ, 39100, Italy

Location

Divisione di Ematologia Ospedale Businco

Cagliari, CA, 09100, Italy

Location

Divisione di Ematologia Ospedale Cardinale Panico

Tricase, LE, 73039, Italy

Location

Divisione di Ematologia Ospedale Niguarda Cà Granda

Milan, MI, 20162, Italy

Location

Divisione di Oncoematologia IRCC

Candiolo, TO, 10060, Italy

Location

Divisione di Ematologia Istituto Nazionale Fondazione Pascale

Napoli, 80131, Italy

Location

SC Ematologia Ospedale Maggiore Università Avogadro

Novara, 28100, Italy

Location

Divisione di Oncoematologia Azienda Ospedalier S. Maria

Terni, 05100, Italy

Location

SCDO Ematologia 2 AOU San Giovanni Battista

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Barbara Botto, MD

  SCDO Ematologia AOU San Giovanni Battista Torino

  STUDY DIRECTOR

• Umberto Vitolo, MD

  SCDO Ematologia 2 AOU San Giovanni Battista Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: September 1, 2011
• Last Updated: December 31, 2012

Record last verified: 2012-12

Locations

IT (12)