Trial Outcomes & Findings for A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma (NCT NCT02472756)
NCT ID: NCT02472756
Last Updated: 2017-08-01
Results Overview
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.
COMPLETED
41 participants
Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
2017-08-01
Participant Flow
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.
Participant milestones
| Measure |
Follicular Lymphoma Participants
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.
|
|---|---|
|
Induction (Approximately 6 Months)
STARTED
|
41
|
|
Induction (Approximately 6 Months)
Treated
|
40
|
|
Induction (Approximately 6 Months)
COMPLETED
|
39
|
|
Induction (Approximately 6 Months)
NOT COMPLETED
|
2
|
|
Maintenance (Approximately 2 Years)
STARTED
|
20
|
|
Maintenance (Approximately 2 Years)
COMPLETED
|
10
|
|
Maintenance (Approximately 2 Years)
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Follicular Lymphoma Participants
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.
|
|---|---|
|
Induction (Approximately 6 Months)
Adverse Event
|
1
|
|
Induction (Approximately 6 Months)
Enrolled But Not Treated
|
1
|
|
Maintenance (Approximately 2 Years)
Lack of Drug
|
7
|
|
Maintenance (Approximately 2 Years)
Progression Disease
|
2
|
|
Maintenance (Approximately 2 Years)
Adverse Event
|
1
|
Baseline Characteristics
A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Follicular Lymphoma Participants
n=40 Participants
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.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)Population: Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome.
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.
Outcome measures
| Measure |
Follicular Lymphoma Participants
n=39 Participants
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.
|
|---|---|
|
Percentage of Participants With Objective Response
|
92.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)Population: ITT population. Number of participants analyzed = participants who were evaluable for this outcome.
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).
Outcome measures
| Measure |
Follicular Lymphoma Participants
n=39 Participants
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.
|
|---|---|
|
Percentage of Participants With Complete Remission (CR)
|
56.4 percentage of participants
|
PRIMARY outcome
Timeframe: Year 2Population: ITT population.
Outcome measures
| Measure |
Follicular Lymphoma Participants
n=40 Participants
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.
|
|---|---|
|
Percentage of Participants Who Were Alive at Year 2
|
85 percentage of participants
|
Adverse Events
Follicular Lymphoma Participants
Serious adverse events
| Measure |
Follicular Lymphoma Participants
n=41 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.3%
3/41 • Up to 30 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/41 • Up to 30 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.9%
2/41 • Up to 30 months
|
|
Blood and lymphatic system disorders
Leukemias acute myeloid
|
2.4%
1/41 • Up to 30 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.4%
1/41 • Up to 30 months
|
|
Immune system disorders
Hypogammaglobulinaemia
|
2.4%
1/41 • Up to 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheitis
|
2.4%
1/41 • Up to 30 months
|
|
Infections and infestations
Hepatitis B
|
2.4%
1/41 • Up to 30 months
|
|
General disorders
Death
|
2.4%
1/41 • Up to 30 months
|
Other adverse events
| Measure |
Follicular Lymphoma Participants
n=41 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.3%
3/41 • Up to 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER