Zevalin Twice in Aggressive Non-Hodgkin Lymphoma

This study has been terminated.
(After enrolling 25 patients an interim analysis was done.The study was discontinued in the absence of the minimum number of 6 patients free of events)
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
ClinicalTrials.gov Identifier:
NCT00902525
First received: May 14, 2009
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Diffuse Large B-Cell Lymphoma
Drug: 90Y-Ibritumomab Tiuxetan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Repeated Doses of Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) as Salvage Treatment for Patients With Relapsed or Refractory Aggressive B-cell Lymphoma: a Phase II Study.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie:

Primary Outcome Measures:
  • 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. [ Time Frame: after the enrolment of the 15th patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: after the enrolment of the 23rd patient ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: September 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 90Y-Ibritumomab Tiuxetan double dose
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
All patients receive 2 courses of age-adjusted R-miniDHAP followed by two doses of 90Y-Ibritumomab Tiuxetan

Detailed Description:

The objectives of this study are to evaluate the efficacy and safety of two sequential doses of 90Y-Ibritumomab Tiuxetan administered after salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma non-eligible for HDC and ASCT.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75
  2. Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
  3. Stage II, III, IV according to Ann Arbor criteria
  4. 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
  5. Performance status 0-2 according to WHO criteria
  6. HIV negativity
  7. 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
  8. 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.
  9. Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
  10. Use of effective contraception for the entire treatment period in patients sexually active
  11. Negative pregnancy test in child bearing potential women
  12. Life expectancy > 6 months
  13. Written informed consent

Exclusion Criteria:

  1. More than two lines of prior chemotherapy before study entry
  2. Prior high dose chemotherapy and autologous stem cell transplantation
  3. HIV positivity
  4. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
  5. HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
  6. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  7. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
  8. 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
  9. Pregnant or breastfeeding
  10. CNS lymphoma involvement.
  11. History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
  12. Cardiac failure with VEF < 40%
  13. Clinical evidence of not controlled infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902525

Locations
Italy
Divisione di Ematologia Ospedale SS Antonio e Biagio
Alessandria, AL, Italy, 15100
Istituto di Ematologia e Oncologia Medica L. Seragnoli Policlinco S. Orsola
Bologna, BO, Italy, 40138
Divisione di Ematologia, Spedali Civili
Brescia, BS, Italy, 25100
Divisione di Ematologia Ospedale Centrale di Bolzano
Bolzano, BZ, Italy, 39100
Divisione di Ematologia Ospedale Businco
Cagliari, CA, Italy, 09100
Divisione di Ematologia Ospedale Cardinale Panico
Tricase, LE, Italy, 73039
Divisione di Ematologia Ospedale Niguarda Cà Granda
Milano, MI, Italy, 20162
Divisione di Oncoematologia IRCC
Candiolo, TO, Italy, 10060
Divisione di Ematologia Istituto Nazionale Fondazione Pascale
Napoli, Italy, 80131
SC Ematologia Ospedale Maggiore Università Avogadro
Novara, Italy, 28100
Divisione di Oncoematologia Azienda Ospedalier S. Maria
Terni, Italy, 05100
SCDO Ematologia 2 AOU San Giovanni Battista
Turin, Italy, 10126
Sponsors and Collaborators
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
Study Director: Barbara Botto, MD SCDO Ematologia AOU San Giovanni Battista Torino
Principal Investigator: Umberto Vitolo, MD SCDO Ematologia 2 AOU San Giovanni Battista Torino
  More Information

No publications provided

Responsible Party: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
ClinicalTrials.gov Identifier: NCT00902525     History of Changes
Other Study ID Numbers: ZETAL07
Study First Received: May 14, 2009
Last Updated: December 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie:
two sequential doses of 90Y-Ibritumomab Tiuxetan

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014