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Lymphoma, Non-HodgkinPhase 2Z0105NCT00354822

Fludarabine,Cyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas.

A Phase 2 study testing Zevalin in people with Lymphoma, Non-Hodgkin, run by A.O. Ospedale Papa Giovanni XXIII at 6 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

Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration (Time to relapse or progression)and to evaluate the… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Zevalin
How many people
25 participants
Where
6 sitesItaly
Study dates
Aug 2005to Aug 2009
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a lymphoma refractory to front-line chemotherapy, not including fludarabine, or in first relapse after chemotherapy not including fludarabine, not suitable for high-dose chemotherapy supported by auto or allogeneic bone marrow transplantation.
  • Histologically-confirmed small lymphocytic (SLL), lymphoplasmacytic (LPL) and marginal zone (MZL) lymphomas.
  • All prior chemotherapy, including corticosteroids, had to have been completed > 4 weeks before study treatment; < 25% of active bone marrow irradiated previously; no prior bone marrow transplantation.
  • Age: 18-70 years
  • ECOG- performance status: 0-2.
  • No allergy to mouse proteins.
Show all 13Show fewer
  • CD20 positive B cell lymphoma.
  • Ann Arbor stage III or IV disease with bidimensionally measurable disease in at least one site which has not irradiated, including any adenopathy or mass that could be measured during a physical examination or that was > 5 cm on a computed tomographic scan (CT). In the event of splenomegaly or hepatomegaly, extension 5 cm below the costal margin was considered evidence of measurable disease. Osteoblastic bone lesions, ascites and pleural effusion are not considered measurable disease.
  • Tumor involvement in the marrow<25% before treatment with Zevalin.
  • Acceptable hematologic status within one week prior study start: Hb>9g/dL, white blood count >3x10^9/L, absolute neutrophil count >1.5x10^9/L, platelets >100x10^9/L.
  • Written informed consent prior to any study specific screening procedures, with the understanding that the patient has the right to withdraw from that study at any time, without prejudice.
  • Patients willing and able to comply with the protocol for the duration of the study.
  • Patients, if sexually active, must agree to be using effective contraception for the entire treatment period and for 1 year following treatment. Women, of child-bearing potential, must have a negative pregnancy test.

Who cannot join

  • Histologies other than those included
  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of cervix within the last 5 years.
  • Major surgery, other than diagnostic surgery, within the last 4 weeks.
  • Presence of malignant ascites or pleural effusions.
  • Evidence of CNS involvement. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication, or myocardial infarction within the last 6 months, NYHA class III or IV heart disease), abnormal liver function tests, not disease related, within 1 week prior to study start (serum bilirubin >2 mg/dL; ALAT >2.5 x upper normal limit; alkaline phosphatase >2.5xupper normal limit), abnormal renal function, not disease related (serum creatinine >2.0 mg/dL), active opportunistic infections.
  • Serum positivity for HIV, HBsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA and HBV-DNA. This latter group of patients can be enrolled in the study, but they will receive lamivudine prophylaxis and bimonthly evaluation of HbSAg, HbCAb and HBV-DNA will be provided.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • USC Ematologia Ospedali Riuniti di Bergamo

    Bergamo, BG, 24128

  • U.O. Ematologia Ospedali Civili Brescia

    Brescia, BS

  • Istituto per la Ricerca e la Cura del Cancro IRCC

    Candiolo, TO, 10060

  • Medicina Nucleare ed Oncologia Medica AOU Policlinico Universitario di Messina

    Messina, ME, 98125

  • SC Ematologia 2 ASO S. Giovanni Battista

    Torino, TO

  • U.O. Ematologia Ospedale Cà Foncello

    Treviso, TV, 31100

Other trials in Italy

About this study

Official title: Phase II Study for Use of Oral Fludarabine Plus Cyclophosphamide and Rituximab Followed by Zevalin as Front-Line Treatment for Non-Follicular Indolent Lymphomas.

Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration (Time to relapse or progression)and to evaluate the safety of the treatment as acute and late toxicity.

Secondary objective is to evaluate the overall survival (OS) and the event-free survival (EFS).

Read the detailed description

Test medication:

  • Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts>150x10^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies.
  • Standard dose chemotherapy consisting of cyclophosphamide, fludarabine and rituximab given every 28 days up to the best response (maximum 6 courses).
  • A prophylaxis for pneumocystis carinii as well as for herpes zoster are needed during treatment.

Main parameters of activity: activity of Yttrium-90 (90Y) ibritumomab tiuxetan after cyclophosphamide, fludarabine and rituximab combination.

Being tested
Zevalin
Keywords
Zevalin, Lymphoma, Non-Hodgkin
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • ZevalinDrug

    Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts>150x10^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies.

What is being measured

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

  1. achievement and duration of complete or partial reduction of lymphnodes six weeks after the end of treatment with zevalin

    Measured: 2 years

Secondary outcomes (1)

  1. overall and event free survival

    Measured: 2 years

Timeline

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

  1. First posted20 Jul 2006 (estimated)
  2. Study startAug 2005
  3. Primary completionAug 2009 (estimated)
  4. Study completionAug 2009

Why it stopped: Inability to recruit in time a sufficient number of patients

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354822
Sponsor's protocol ID
EUDRACT 2005-000699-41
Acronym
Z0105
Status last verified
Sep 2009
First submitted
19 Jul 2006
Last updated
18 Sep 2009
Results posted
No
Data monitoring committee
No

Publications

  • Brandt L, Kimby E, Nygren P, Glimelius B; SBU-group. Swedish Council of Technology Assessment in Health Care. A systematic overview of chemotherapy effects in indolent non-Hodgkin's lymphoma. Acta Oncol. 2001;40(2-3):213-23. doi: 10.1080/02841860151116286.

    PubMed 11441933

  • Solal-Celigny P, Brice P, Brousse N, Caspard H, Bastion Y, Haioun C, Bosly A, Tilly H, Bordessoule D, Sebban C, Harousseau JL, Morel P, Dupas B, Plassart F, Vasile N, Fort N, Leporrier M. Phase II trial of fludarabine monophosphate as first-line treatment in patients with advanced follicular lymphoma: a multicenter study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 1996 Feb;14(2):514-9. doi: 10.1200/JCO.1996.14.2.514.

    PubMed 8636765

  • Santini G, Nati S, Spriano M, Gallamini A, Pierluigi D, Congiu AM, Truini M, Rubagotti A, Chisesi T, Vimercati R, Rossi E, Sertoli MR, Mattei D, Marino G, Gobbi M. Fludarabine in combination with cyclophosphamide or with cyclophosphamide plus mitoxantrone for relapsed or refractory low-grade non-Hodgkin's lymphoma. Haematologica. 2001 Mar;86(3):282-6.

    PubMed 11255275

  • Hiddemann W, Dreyling M, Unterhalt M. Rituximab plus chemotherapy in follicular and mantle cell lymphomas. Semin Oncol. 2003 Feb;30(1 Suppl 2):16-20. doi: 10.1053/sonc.2003.50024.

    PubMed 12652460

  • Witzig TE, Flinn IW, Gordon LI, Emmanouilides C, Czuczman MS, Saleh MN, Cripe L, Wiseman G, Olejnik T, Multani PS, White CA. Treatment with ibritumomab tiuxetan radioimmunotherapy in patients with rituximab-refractory follicular non-Hodgkin's lymphoma. J Clin Oncol. 2002 Aug 1;20(15):3262-9. doi: 10.1200/JCO.2002.11.017.

    PubMed 12149300

  • Witzig TE, Gordon LI, Cabanillas F, Czuczman MS, Emmanouilides C, Joyce R, Pohlman BL, Bartlett NL, Wiseman GA, Padre N, Grillo-Lopez AJ, Multani P, White CA. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2002 May 15;20(10):2453-63. doi: 10.1200/JCO.2002.11.076.

    PubMed 12011122

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zevalin in people with Lymphoma, Non-Hodgkin, run by A.O. Ospedale Papa Giovanni XXIII at 6 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 7 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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: Inability to recruit in time a sufficient number of patients). 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?

achievement and duration of complete or partial reduction of lymphnodes six weeks after the end of treatment with zevalin (time frame: 2 years). 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 NCT00354822, which also lists 6 linked publications.

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 18 Sep 2009.

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