Fludarabine,Cyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas. (Z0105)

September 17, 2009 updated by: A.O. Ospedale Papa Giovanni XXIII

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BG
      • Bergamo, BG, Italy, 24128
        • USC Ematologia Ospedali Riuniti di Bergamo
    • BS
      • Brescia, BS, Italy
        • U.O. Ematologia Ospedali Civili Brescia
    • ME
      • Messina, ME, Italy, 98125
        • Medicina Nucleare ed Oncologia Medica AOU Policlinico Universitario di Messina
    • TO
      • Candiolo, TO, Italy, 10060
        • Istituto per la Ricerca e la Cura del Cancro IRCC
      • Torino, TO, Italy
        • SC Ematologia 2 ASO S. Giovanni Battista
    • TV
      • Treviso, TV, Italy, 31100
        • U.O. Ematologia Ospedale Cà Foncello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
achievement and duration of complete or partial reduction of lymphnodes six weeks after the end of treatment with zevalin
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall and event free survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborators

Regional Hospital of Bolzano

Investigators

  • Principal Investigator: Cortelazzo Sergio, MD, Ospedale Centrale di Bolzano (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT 2005-000699-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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