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Follicular LymphomaPhase 2NCT00393107

Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

A Phase 2 study testing rituximab and rituximab,fludarabine, cyclophosphamide in people with Follicular Lymphoma, run by Gruppo Italiano Studio Linfomi at 9 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Follicular Lymphoma
What is being tested?
rituximab and rituximab,fludarabine, cyclophosphamide
How many people
54 participants
Where
9 sitesItaly
Study dates
Mar 2000to Aug 2006
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

  • histologically documented WHO grade 1-2 ,CD20+,follicular lymphoma
  • relapsed Follicular lymphoma
  • stage III or IV disease
  • Stage II patients are eligible if they present with B symptoms or bulky disease
  • to have a need for therapy in the opinion of treating clinician
  • measurable disease
Show all 10Show fewer
  • expected survival of 6 months or more
  • age 18 to 70 years
  • to have undergone < 3 lines of chemotherapy
  • performance status of 0 to 2

Who cannot join

  • known HIV infections
  • Known Hepatitis B or C
  • CNS lymphoma
  • previous malignancies, or cardiac, renal, hepatic, or respiratory failure
  • Pregnant or lactating women and patients of child bearing potential unless using birth control measures

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Italy9 sites

  • Ospedale di Arezzo

    Arezzo, 52100

  • Ospedale Maggiore di Milano

    Milan, 20100

  • Ospedale Monteluce

    Perugia, 06110

  • Ospedale di Pescara

    Pescara, 89100

  • Ospedale di Piacenza

    Piacenza, 29100

  • Ospedale di Pisa

    Pisa, 56100

  • Ospedale di Reggio Calabria

    Reggio Calabria, 89100

  • Ospedale S. Maria Nuova

    Reggio Emilia, 42100

  • Ospedale Molinette

    Torino, 10100

Other trials in Italy

About this study

Official title: Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma

Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination.

Read the detailed description

The natural history of follicular lymphomas is characterized by a high initial response rate to chemotherapy followed invariably by relapse, with subsequent remissions of progressively shorter duration. The majority of patients eventually die of their disease. As yet, there is no gold standard for the treatment of newly diagnosed or relapsed advanced FL.Rituximab(R) has been shown to be a highly effective agent in the treatment of FL, either alone or in combination with chemotherapy. The ability of R to sensitize indolent lymphoma derived cell lines to cytotoxic chemotherapy agents has been demonstrated. Furthermore, fludarabine (F) may also sensitize cells to the effects of R. Cyclophosphamide (C) and F have shown in vivo synergistic activity. In view of the single agent activity and demonstrated synergy between C and F, and between F and R, we evaluated FC+R in previously treated patients with advanced FL. The primary aim of this study was to assess the safety profile and clinical activity of the FC+R combination. The secondary goal was to evaluate the ability of the treatment to convert bone marrow Bcl2 positivity such that patients achieved molecular remissions.

Being tested
rituximab, rituximab,fludarabine, cyclophosphamide
Keywords
follicular lymphoma, non-Hodgkin lymphoma, Fludarabine, Cyclophosphamide, Rituximab, combination, immuno-chemotherapy, relapsed
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Recurrence

What participants receive

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

  • rituximabDrug

  • rituximab,fludarabine, cyclophosphamideDrug

What is being measured

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

  1. Toxicity during the treatment period

  2. Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy

Secondary outcomes (1)

  1. Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment)

Timeline

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

  1. First posted26 Oct 2006 (estimated)
  2. Study startMar 2000
  3. Study completionAug 2006

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
54 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393107
Sponsor's protocol ID
FR2
Other IDs
FolRec02, GislFR2
Status last verified
Oct 2006
First submitted
25 Oct 2006
Last updated
26 Oct 2006
Results posted
No

Publications

  • Alas S, Bonavida B. Rituximab inactivates signal transducer and activation of transcription 3 (STAT3) activity in B-non-Hodgkin's lymphoma through inhibition of the interleukin 10 autocrine/paracrine loop and results in down-regulation of Bcl-2 and sensitization to cytotoxic drugs. Cancer Res. 2001 Jul 1;61(13):5137-44.

    PubMed 11431352

  • Alas S, Emmanouilides C, Bonavida B. Inhibition of interleukin 10 by rituximab results in down-regulation of bcl-2 and sensitization of B-cell non-Hodgkin's lymphoma to apoptosis. Clin Cancer Res. 2001 Mar;7(3):709-23.

    PubMed 11297268

  • Di Gaetano N, Xiao Y, Erba E, Bassan R, Rambaldi A, Golay J, Introna M. Synergism between fludarabine and rituximab revealed in a follicular lymphoma cell line resistant to the cytotoxic activity of either drug alone. Br J Haematol. 2001 Sep;114(4):800-9. doi: 10.1046/j.1365-2141.2001.03014.x.

    PubMed 11564066

  • Bellosillo B, Villamor N, Colomer D, Pons G, Montserrat E, Gil J. In vitro evaluation of fludarabine in combination with cyclophosphamide and/or mitoxantrone in B-cell chronic lymphocytic leukemia. Blood. 1999 Oct 15;94(8):2836-43.

    PubMed 10515887

  • Sacchi S., Tucci A, Merli F, Orsucci L, Cervetti G, Occhini U, Liberati M, Tarantini G, Callea V, Brugiatelli M, Lauta VM, Baldini L, Luminari S, Federico M. Dipartimento di Oncologia ed Ematologia,. Phase II Study with Fludarabine and Cyclophosphamide Plus Rituximab (FC+R) in Relapsed Follicular Lymphoma Patients. ASH 2002. Blood 99, 2002 Ab n° 530

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab and rituximab,fludarabine, cyclophosphamide in people with Follicular Lymphoma, run by Gruppo Italiano Studio Linfomi at 9 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Toxicity during the treatment period. The study lists 2 primary outcomes in all. 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 NCT00393107, which also lists 5 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 26 Oct 2006.

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