Follicular LymphomaNCT02461290
Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
An observational study of Follicular Lymphoma, run by Hoffmann-La Roche at 6 sites in Serbia.
Trial summary
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens. 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?
- Chemotherapy and Rituximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 99 participants
- Where
- 6 sitesSerbia
- Study dates
- Apr 2008to Nov 2013
- Phase
- Observational
- 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
Study population: Patients with follicular lymphoma
Who may be able to join
- New diagnosed Stage III/IV NHLs
- Grades 1, 2 follicular lymphoma need to be treated
- mCD20 positive
- Have an expected survival of 3 months or more
- ECOG 0-2 grade
- Normal renal function
- ALT less than double normal level
Who cannot join
- Presence of CNS lymphoma
- Severe infectious disease or organic disease
- Having another malignant tumor
- Pregnant or breast-feeding female
- Organic heart disease, heart failure, II or higher grade AV bundle block.
- Subject is allergic to Rituximab
- Known HIV infection or chronic HBV infection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Serbia6 sites
Study site
Belgrade, 11000
Study site
Belgrade, 11080
Study site
Kamenitz, 21204
Study site
Kragujevac, 34000
Study site
Niš, 18000
Study site
Novi Sad, 21000
About this study
Official title: Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
- Conditions
- Follicular Lymphoma
- Being tested
- Chemotherapy, 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.
ChemotherapyRadiation
RituximabDrug
Also called MabThera
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens. Receives: Radiation: Chemotherapy; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.
Measured: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Secondary outcomes (3)
Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)
Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Measured: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants With CR According to International Working Group Response Criteria for NHL
Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Measured: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants Alive at 1, 2, and 3 Years
Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.
Measured: At 1, 2, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startApr 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461290
- Sponsor's protocol ID
- ML21526
- Status last verified
- Aug 2015
- First submitted
- 29 May 2015
- Last updated
- 30 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT02461290
- Acronym / sponsor ID
- ML21526
- Conditions
- Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 30 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | – | Radiation: Chemotherapy, Drug: RituximabRituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with follicular lymphoma
Key inclusion criteria (7 listed)
- New diagnosed Stage III/IV NHLs
- Grades 1, 2 follicular lymphoma need to be treated
- mCD20 positive
- Have an expected survival of 3 months or more
- ECOG 0-2 grade
Key exclusion criteria (7 listed)
- Presence of CNS lymphoma
- Severe infectious disease or organic disease
- Having another malignant tumor
- Pregnant or breast-feeding female
- Organic heart disease, heart failure, II or higher grade AV bundle block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy | Radiation | Combination Therapy |
| RituximabAlso: MabThera | Drug | Combination Therapy |
Primary outcome
Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
Time frame: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.
3 secondary outcomes
Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)
Time frame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants With CR According to International Working Group Response Criteria for NHL
Time frame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants Alive at 1, 2, and 3 Years
Time frame: At 1, 2, and 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by Hoffmann-La Roche at 6 sites in Serbia.
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 7 inclusion and 7 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 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Serbia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 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?
Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE (time frame: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2015.