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AzTrials

Follicular LymphomaPhase 2GOTEL-FL1LCNCT00722930

Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma

A Phase 2 study testing Y90 Ibritumomab Tiuxetan in people with Follicular Lymphoma, run by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas at 11 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Y90 Ibritumomab Tiuxetan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
11 sitesSpain
Study dates
Apr 2008to Apr 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure.
  • Patients older than 18.
  • Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.
  • High-risk patients according to FLIPI before initiation of induction chemotherapy.
  • Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.
  • Complete or partial response to the induction scheme.
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  • ECOG scale performance status 0 - 2.
  • Life expectancy greater than 3 months.
  • In women of childbearing age, use of a reliable contraceptive method.
  • A suitable bone marrow reserve:
  • Lower than 25% Bone marrow infiltration by lymphoma.
  • Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
  • Suitable hepatic, renal and cardiac function:
  • creatinine <2,5 x UNL (upper normality limit).
  • bilirubin or ALT/AST < 2,5 x UNL

Who cannot join

  • Patients with no objective clinical response to induction chemotherapy.
  • > 25% bone marrow infiltration following induction chemotherapy.
  • Platelets < 100,000 before radioimmunotherapy.
  • Severe and/or uncontrolled concomitant disease:
  • Hepatic, renal, cardiovascular, neurological or metabolic disease.
  • Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.
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  • Positive regarding HBV, HCV, HIV.
  • Active acute or chronic infection.
  • Social, psychic or geographic disability to satisfy any of the treatment schemes.
  • Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.
  • Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).

Trial locations and contacts

11 sites in 1 country.

Mariano Provencio, MD contact

+34-91-344-57-60

mprovenciop@yahoo.es

Sandra Cerdeira, Secretary contact

34 91 3445131

secretariatecnica@grupolinfomas.es

11 sites in 1 country

Spain11 sites, 1 recruiting

  • Instituto Oncológico San Sebastián

    Donostia / San Sebastian, San Sebastián

    Active, not recruiting

  • Hospital Virgen de las Nieves

    Granada, Granada

    Active, not recruiting

  • Clinia Puerta de Hierro

    Madrid, Madrid

    Mariano Provencio, MD

    Recruiting

  • Clínica Ruber Internacional

    Madrid, Madrid

    Active, not recruiting

  • Hospital Virgen de la Victoria

    Málaga, Malaga

    Active, not recruiting

  • Complejo Hospitalario de Pontevedra

    Pontevedra, Pontevedra

    Active, not recruiting

  • Hospital Sant Joan de Reus

    Reus, Tarragona

    Active, not recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz de Tenerife

    Active, not recruiting

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla

    Active, not recruiting

  • Hospital Virgen de la Salud de Toledo

    Toledo, Toledo

    Active, not recruiting

  • Hospital Universitario La Fe

    Valencia, Valencia

    Active, not recruiting

Other trials in Spain

About this study

Official title: Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy

To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy

Being tested
Y90 Ibritumomab Tiuxetan
Keywords
Follicular Lymphoma, High-risk FLIPI, R-CHOP, GOTEL, Partial, Complete, Response, Induction, Chemotherapy
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • Y90 Ibritumomab TiuxetanDrug

    Consolidation with Y90 Ibritumomab Tiuxetan

Study groups in NCT00722930
Study groupRoleWhat they receive
1. Consolidation with Y90 Ibritumomab TiuxetanExperimental1. Consolidation with Y90 Ibritumomab Tiuxetan
Receives: Drug: Y90 Ibritumomab Tiuxetan

What is being measured

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

  1. CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease

    Measured: 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter

Secondary outcomes (10)

  1. Objective clinical response rate (complete + partial).

    Measured: 3 months

  2. Response conversion rate

    Measured: 3 months

  3. Incidence of complete molecular responses

    Measured: 3 months

  4. Response duration

    Measured: 36 months

  5. Event-free survival.

    Measured: 36 months

  6. Progression-free survival

    Measured: 36 months

  7. Time to salvage therapy

    Measured: 36 months

  8. Lymphoma-free or specific cause-free survival

    Measured: 36 months

  9. Overall survival

    Measured: 60 months

  10. Toxicity profile and safety of the consolidation

    Measured: 60 months

Timeline

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

  1. First posted28 Jul 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2011 (estimated)
  4. Study completionApr 2013 (estimated)

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
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722930
Sponsor's protocol ID
GOTEL-FL1LC-0701
Other IDs
Eudra-CT 2007-003091-19
Acronym
GOTEL-FL1LC
Status last verified
Jul 2008
First submitted
25 Jul 2008
Last updated
28 Jul 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Y90 Ibritumomab Tiuxetan in people with Follicular Lymphoma, run by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas at 11 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 15 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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?

Results are not available in the source record.

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

Contact Mariano Provencio, MD (+34-91-344-57-60, mprovenciop@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease (time frame: 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter). 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 NCT00722930.

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 28 Jul 2008; AzTrials last refreshed its copy on 8 Nov 2026.

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