AzTrials
AzTrials

Non Hodgkin LymphomaPhase 4NCT01124526

Efficacy Response Duration and Toxicity of Rituximab, Fludarabine, and Cyclophosphamide (RFC) as 1st Line Treatment and Rituximab (R) in Maintenance Treatment in Follicular Non Hodgkin (FNH) Lymphoma

A Phase 4 study testing Rituximab Fludarabine Cyclophosphamide in people with Non Hodgkin Lymphoma, run by Asociacion Espanola de Hematologia y Hemoterapia at 20 sites in Spain.

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

The purpose of this study is to determine whether the rituximab administration with fludarabine and cyclophosphamide results, are better, than the ones obtained with conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and also to determine whether the rituximab administration as… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
Rituximab Fludarabine Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
20 sitesSpain
Study dates
Sep 2004to Jul 2008
Phase
Phase 4
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

  • Previously untreated patients with grade I-III follicular lymphoma (grade B- D from the Working Formulation, centrofollicular lymphoma in the REAL classification), without evidence of histological transformation.
  • Clinical diagnose by histological and/or immunophenotypical evaluation with positive results for CD 20 Mo Ab (node, bone marrow).
  • Ann-Arbor stage II-IV.
  • Male and female patients from 18 to 75 years old.
  • Lack of related clinically uncontrolled diseases.
  • Lack of VIH infection.
Show all 9Show fewer
  • Performance status (ECOG) of 0, 1, 2.
  • Patients who voluntarily gave informed consent for the study participation.
  • Life expectancy > 3 months.

Who cannot join

  • Pregnant or breast-feeding women.
  • Women of childbearing age who do not accept to use an effective contraceptive method during the treatment and one year post-treatment.
  • Immunodeficiency condition and autoimmune diseases.
  • Patients with advanced clinically uncontrolled cardiac, hepatic or renal insufficiency, defined by the following criteria: total bilirubin, alkaline phosphatase or transaminases >2 x upper limit of normal, and serum creatinine value >2 x upper limit of normal.
  • Patients previously treated with chemotherapy or radiotherapy.
  • History of oncologic disease within the last 5 years, apart from non-melanoma cutaneous neoplasia or carcinoma in situ of uterine cervix.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Fundación Hospital Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Infanta Cristina

    Badajoz, Badajoz_Extremadura, 06080

  • Hospital del Mar

    Barcelona, Barcelona_ Cataluña, 08003

  • Instituto Catalán de Oncología (ICO)

    Barcelona, Barcelona_Cataluña, 08907

  • Hospital San Pedro de Alcántara

    Cáceres, Cáceres_Extremadura, 10003

  • Hospital de Fuenlabrada

    Fuenlabrada, Madrid, 28943

  • Hospital Severo Ochoa

    Leganés, Madrid, 28911

  • Complejo Hospitalario Xeral_Calde

    Lugo, Lugo_ Galicia, 27004

  • MD Anderson Internacional España

    Madrid, Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital de Móstoles

    Móstoles, Madrid, 28935

  • Hospital de Puerto Real

    Puerto Real, Cádiz_ Andalucía, 11510

  • Hospital Clínico Universitario de Salamanca

    Salamanca, Salamanca_Castilla León, 37007

  • Hospital General de Segovia

    Segovia, Segovia_ Castilla León, 40001

  • Hospital Clínico del Río Hortega

    Valladolid, Valladolid_Castilla León, 47010

Other trials in Spain

About this study

Official title: Prospective Non-randomized Multicenter Study to Assess the Efficacy Response Duration and Toxicity of RFC as First-line Treatment and R as Maintenance Treatment, in Patients Diagnosed of Follicular Non Hodgkin Lymphoma

The purpose of this study is to determine whether the rituximab administration with fludarabine and cyclophosphamide results, are better, than the ones obtained with conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and also to determine whether the rituximab administration as maintenance treatment during two years, increase the global clinical responses and the disease free time interval.

Read the detailed description

The use of monoclonal antibodies, specifically the chimerical humanized anti-CD20 monoclonal antibody (Rituximab, MabThera®) represents one of the most innovative aspects in the indolent lymphoma treatment. Preliminary data show from 40% to 50% of response with a median response duration between 6 and 11 months in patients with relapsing FL. This response rate increase when rituximab is administered as initial treatment.

Therefore, not only due to the clinical results but also to the tolerance, and based on an innovative mechanism of action and in its minimal toxicity, it seems reasonable to raise the possibility to incorporate the administration of the monoclonal antibody with chemotherapeutic agents.

The development of a new treatment scheme that includes Rituximab administration within treatment protocols that combine fludarabine and cyclophosphamide, whose results are better than the ones obtained with conventional treatments such as CHOP, should increase the molecular response rate and contribute therefore to increase the disease-free time interval (time to progression), without adding any toxicity, in addition to achieve a higher proportion of clinical responses (as global as complete responses). In order to increase the time interval to progression, a maintenance treatment will be carried out for 2 years, which has shown an evident benefit in the time to progression in preliminary studies.

Being tested
Rituximab Fludarabine Cyclophosphamide
Keywords
R F C treatment in patients with Non Hodgkin Lymphoma
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.

  • Rituximab Fludarabine CyclophosphamideDrug

    Also called MABTHERA, BENEFLUR, GENOXAL

    Patients receiving from 4 to 6 cycles of chemotherapy (R F C) each 4 weeks depending on haematological tolerance:

    RITUXIMAB(R)375 mg/m2 iv,day 3 C1 and day 1 C2-C6,(total dose 375 mg/m2) FLUDARABINE(F):25 mg/m2 iv, day 1-3,(total dose 75 mg/m2) CICLOPHOSPHAMIDE(C)1000 mg/m2 iv, day 1,(total dose 1000 mg/m2)

Study groups in NCT01124526
Study groupRoleWhat they receive
Rituximab, Fludarabine, ciclophosphamideExperimentalPatients receiving from 4 to 6 cycles of chemotherapy (R F C) each 4 weeks depending on haematological tolerance: RITUXIMAB(R)375 mg/m2 iv,day 3 C1 and day 1 C2-C6,(total dose 375 mg/m2)
Receives: Drug: Rituximab Fludarabine Cyclophosphamide

What is being measured

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

  1. Time to progression disease

    Measured: 42 months

Secondary outcomes (4)

  1. Free-disease period

    Measured: 54 months

  2. Overall survival

    Measured: 54 months

  3. Safety of RFC

    Toxicity is detailed and tabulate following the WHO classification. The safety analysis includes the incidence of adverse events (AE),vital signs and laboratory parameters.

    Impact tables are made of AE following the classification of preferred term. Also include an analysis of the intensity of AE and their relation to the combiantion of study treatment.

    Measured: 54 months

  4. Molecular monitoring of clinical response

    Study of t14:18 translocation with altered expression of BCL2.

    Measured: 54 months

Timeline

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

  1. First posted17 May 2010 (estimated)
  2. Study startSep 2004
  3. Primary completionJul 2007
  4. Study completionJul 2008

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01124526
Sponsor's protocol ID
LNHF-03.
Other IDs
04-0199, 2004/254
Status last verified
May 2010
First submitted
10 Feb 2009
Last updated
17 May 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rituximab Fludarabine Cyclophosphamide in people with Non Hodgkin Lymphoma, run by Asociacion Espanola de Hematologia y Hemoterapia at 20 sites in Spain.

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 9 inclusion and 6 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 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Time to progression disease (time frame: 42 months). 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 NCT01124526.

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 17 May 2010.

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