REFLECT 2: A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma
Study Details
Study Description
Brief Summary
This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible participants with FL will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. Participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. The choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Follicular Lymphoma Participants Previously treated adult participants with relapsed/refractory FL will receive rituximab in combination with chemotherapy regimen. All treatments prescribed during the observation period will be at the treating physician's discretion. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. |
Drug: Chemotherapy
The choice of the chemotherapy regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
Drug: Rituximab
The choice of the rituximab regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Objective Response [Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)]
Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD.
- Percentage of Participants With Complete Remission (CR) [Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)]
Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline).
- Percentage of Participants Who Were Alive at Year 2 [Year 2]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Participants diagnosed with FL and had already received one or more treatments
Exclusion Criteria:
- Participants who are not eligible for rituximab treatment according to summary of product characteristics (SmPC)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Hematology | Belgrade | Serbia | 11000 | |
| 2 | Clinical Center Bezanijska Kosa | Belgrade | Serbia | 11070 | |
| 3 | Clinical Center Kragujevac | Kragujevac | Serbia | 34000 | |
| 4 | Clinic of Haematology Cc Nis | NIS | Serbia | 18000 | |
| 5 | Clinical Center Vojvodine; Clinic for Hematology | Novi Sad | Serbia | 21000 | |
| 6 | Institute For Oncology Sremska Kamenica; Internal Medicine Department | Sremska Kamenica | Serbia | 21204 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML21872
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | All treatments prescribed during the observation period were at the treating physician's discretion and should have been prescribed according to package labeling, within approved indication and local approval status of respective drugs. |
| Arm/Group Title | Follicular Lymphoma Participants |
|---|---|
| Arm/Group Description | Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. |
| Period Title: Induction (Approximately 6 Months) | |
| STARTED | 41 |
| Treated | 40 |
| COMPLETED | 39 |
| NOT COMPLETED | 2 |
| Period Title: Induction (Approximately 6 Months) | |
| STARTED | 20 |
| COMPLETED | 10 |
| NOT COMPLETED | 10 |
Baseline Characteristics
| Arm/Group Title | Follicular Lymphoma Participants |
|---|---|
| Arm/Group Description | Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. |
| Overall Participants | 40 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
55
|
| Sex: Female, Male (Count of Participants) | |
| Female |
26
65%
|
| Male |
14
35%
|
Outcome Measures
| Title | Percentage of Participants With Objective Response |
|---|---|
| Description | Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD. |
| Time Frame | Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome. |
| Arm/Group Title | Follicular Lymphoma Participants |
|---|---|
| Arm/Group Description | Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. |
| Measure Participants | 39 |
| Number [percentage of participants] |
92.3
230.8%
|
| Title | Percentage of Participants With Complete Remission (CR) |
|---|---|
| Description | Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). |
| Time Frame | Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Number of participants analyzed = participants who were evaluable for this outcome. |
| Arm/Group Title | Follicular Lymphoma Participants |
|---|---|
| Arm/Group Description | Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. |
| Measure Participants | 39 |
| Number [percentage of participants] |
56.4
141%
|
| Title | Percentage of Participants Who Were Alive at Year 2 |
|---|---|
| Description | |
| Time Frame | Year 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. |
| Arm/Group Title | Follicular Lymphoma Participants |
|---|---|
| Arm/Group Description | Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. |
| Measure Participants | 40 |
| Number [percentage of participants] |
85
212.5%
|
Adverse Events
| Time Frame | Up to 30 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Follicular Lymphoma Participants | |
| Arm/Group Description | Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. | |
All Cause Mortality |
||
| Follicular Lymphoma Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Follicular Lymphoma Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/41 (19.5%) | |
| Blood and lymphatic system disorders | ||
| Thrombocytopenia | 3/41 (7.3%) | |
| Neutropenia | 1/41 (2.4%) | |
| Leukopenia | 2/41 (4.9%) | |
| Leukemias acute myeloid | 1/41 (2.4%) | |
| Pancytopenia | 1/41 (2.4%) | |
| General disorders | ||
| Death | 1/41 (2.4%) | |
| Immune system disorders | ||
| Hypogammaglobulinaemia | 1/41 (2.4%) | |
| Infections and infestations | ||
| Hepatitis B | 1/41 (2.4%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Tracheitis | 1/41 (2.4%) | |
Other (Not Including Serious) Adverse Events |
||
| Follicular Lymphoma Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/41 (7.3%) | |
| Blood and lymphatic system disorders | ||
| Neutropenia | 3/41 (7.3%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffman-La Roche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
- ML21872