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Diffuse Large B-Cell LymphomaPhase 2NCT00902525

Zevalin Twice in Aggressive Non-Hodgkin Lymphoma

A Phase 2 study testing 90Y-Ibritumomab Tiuxetan in people with Diffuse Large B-Cell Lymphoma, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 12 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
90Y-Ibritumomab Tiuxetan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
12 sitesItaly
Study dates
Jan 2008to Sep 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Italy12 sites

  • Divisione di Ematologia Ospedale SS Antonio e Biagio

    Alessandria, AL, 15100

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

    Bologna, BO, 40138

  • Divisione di Ematologia Ospedale Centrale di Bolzano

    Bolzano, BZ, 39100

  • Divisione di Ematologia, Spedali Civili

    Brescia, BS, 25100

  • Divisione di Ematologia Ospedale Businco

    Cagliari, CA, 09100

  • Divisione di Oncoematologia IRCC

    Candiolo, TO, 10060

  • Divisione di Ematologia Ospedale Niguarda Cà Granda

    Milan, MI, 20162

  • Divisione di Ematologia Istituto Nazionale Fondazione Pascale

    Naples, 80131

  • SC Ematologia Ospedale Maggiore Università Avogadro

    Novara, 28100

  • Divisione di Oncoematologia Azienda Ospedalier S. Maria

    Terni, 05100

  • Divisione di Ematologia Ospedale Cardinale Panico

    Tricase, LE, 73039

  • SCDO Ematologia 2 AOU San Giovanni Battista

    Turin, 10126

Other trials in Italy

About this study

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.

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.

Read the 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.

Being tested
90Y-Ibritumomab Tiuxetan
Keywords
two sequential doses of 90Y-Ibritumomab Tiuxetan
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 90Y-Ibritumomab TiuxetanDrug

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

Study groups in NCT00902525
Study groupRoleWhat they receive
90Y-Ibritumomab Tiuxetan double doseExperimental90Y-Ibritumomab Tiuxetan administered at 0.4 mCi/kg at phase 2 and then at 0.2 mCi/kg at phase 3
Receives: Drug: 90Y-Ibritumomab Tiuxetan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: after the enrolment of the 15th patient

Secondary outcomes (1)

  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.

    Measured: after the enrolment of the 23rd patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2009 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2009
  4. Study completionSep 2011

Why it stopped: 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00902525
Sponsor's protocol ID
ZETAL07
Status last verified
Dec 2012
First submitted
14 May 2009
Last updated
31 Dec 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 90Y-Ibritumomab Tiuxetan in people with Diffuse Large B-Cell Lymphoma, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00902525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2012.

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