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Lymphoma, FollicularPhase 3NCT02569996

A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

A Phase 3 study testing Rituximab in people with Lymphoma, Follicular, run by Hoffmann-La Roche at 21 sites in Hungary.

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

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular
What is being tested?
Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
21 sitesHungary
Study dates
Jul 2005to Aug 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult participants greater than (>) 18 years of age
  • Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
  • No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
  • Verified complete or partial remission after first-line induction therapy including rituximab

Who cannot join

  • Grade 3b follicular lymphoma
  • Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
  • Presence of central nervous system lymphoma
  • Acquired immunodeficiency syndrome-related lymphoma
  • Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (>=) 5 years

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Hungary21 sites

  • Study site

    Budapest, 1071

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1085

  • Study site

    Budapest, 1088

  • Study site

    Budapest, 1122

  • Study site

    Budapest, 1135

  • Study site

    Debrecen, 4032

  • Study site

    Győr, 9024

  • Study site

    Gyula, 5700

  • Study site

    Kaposvár, 7400

  • Study site

    Miskolc, 3529

  • Study site

    Nyíregyháza, 4400

  • Study site

    Pécs, 7624

  • Study site

    Szeged, 6720

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szekszárd, 7100

  • Study site

    Szolnok, 5004

  • Study site

    Szombathely, 9700

  • Study site

    Tatabánya, 2800

  • Study site

    Veszprém, 8200

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

About this study

Official title: A Multicenter, Phase III, Open-label Study Evaluating the Benefit of a Long-term Effect of MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma After Induction of Response (CR[u] or PR) With MabThera (Rituximab) Containing First-line Regimen

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

Being tested
Rituximab
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • RituximabDrug

    Also called MabThera/Rituxan

    Rituximab will be administered at 375 mg/m^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.

Study groups in NCT02569996
Study groupRoleWhat they receive
RituximabExperimentalParticipants will receive rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Receives: Drug: Rituximab

What is being measured

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

  1. Event-free Survival

    Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.

    Measured: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years

Secondary outcomes (6)

  1. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death

    Measured: Up to 27 months

  2. Overall Survival (OS)

    Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

    Measured: From randomization until death, assessed up to 5 years

  3. Time to Progression (TTP)

    Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

    Measured: From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years

  4. Time to Next Anti-lymphoma Treatment (TTNLT)

    Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

    Measured: From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years

  5. Duration of Response (DR)

    Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

    Measured: From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years

  6. Disease-free Survival (DFS)

    Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

    Measured: From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years

Timeline

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

  1. First posted7 Oct 2015 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2013
  4. Study completionAug 2013

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569996
Sponsor's protocol ID
ML18167
Status last verified
Nov 2015
First submitted
23 Sep 2015
Last updated
10 Dec 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Lymphoma, Follicular, run by Hoffmann-La Roche at 21 sites in Hungary.

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 4 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Hungary. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Event-free Survival (time frame: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 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 NCT02569996.

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 10 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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