A Phase 3 interventional study of Rituximab and Cyclophosphamide in Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche. Completed at 13 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).
2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.
This study's enrollment of 139 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone · Drug: Fludarabine
Rituximab SC 1400 mg
Also known as: MabThera®
Cyclophosphamide will be administered as per standard local practice.
Also known as: Endoxan
Doxorubicin will be administered as per standard local practice.
Vincristine will be administered as per standard local practice.
Prednisone will be administered as per standard local practice.
Fludarabine will be administered as per standard local practice.
Percentage of Participants With Administration-Associated Reactions (AARs)
AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.
Time frame: Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)
Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria
EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.
Time frame: From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])
Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria
PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.
Time frame: From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])
Overall Survival (OS)
OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.
Time frame: From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])
Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria
DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.
Time frame: From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months])
Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria
CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999).
Time frame: From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])
Healthcare Professional Questionnaire Score
Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report
Time frame: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)
Patient-Reported Rituximab Administration Questionnaire (RASQ) Score
The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range. For each domain was scored using the following formula: Domain score = \[(Sum of completed item (question) responses / Number of completed items) - 1\] x 100 / (Maximum possible item response value - Minimum possible item response value) The final RASQ domains is calculated using the formula: RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants.
Time frame: Up to 53.8 Months
Total of 139 participants mentioned below in the table were recruited and enrolled.
| Milestone | DLBCL Arm | FL Arm |
|---|---|---|
| Started | 105 | 34 |
| Completed | 67 | 21 |
| Not completed | 38 | 13 |
| Withdrew: Screen failure | 10 | 7 |
| Withdrew: Death | 22 | 5 |
| Withdrew: Lost to follow-up | 4 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.
| Percentage of Participants % | DLBCL Arm | FL Arm | Overall Population |
|---|---|---|---|
| Blood And Lymphatic System Disorders, And Lymphatic System Disorders, Anaemia | 1.1 | 3.7 | 1.6 |
| Blood And Lymphatic System Disorders, Leukopenia | 1.1 | 0 | 0.8 |
| Blood And Lymphatic System Disorders, Thrombocytopenia | 1.1 | 0 | 0.8 |
| General Disorders And Administration Site Conditions, Injection Site Erythema | 4.2 | 7.4 | 4.9 |
| General Disorders And Administration Site Conditions, Injection Site, Injection Site Pain | 4.2 | 0 | 3.3 |
| Nervous System Disorders, Burning Sensation | 2.1 | 0 | 1.6 |
| Nervous System Disorders, Paraesthesia | 1.1 | 0 | 0.8 |
| Skin And Subcutaneous Tissue Disorders, Erythema | 2.1 | 0 | 1.6 |
| Skin And Subcutaneous Tissue Disorders, Dermatitis Allergic | 1.1 | 0 | 0.8 |
EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.
| Months | DLBCL Arm | FL Arm | Overall |
|---|---|---|---|
| From first dose of rituximab IV | NA (33.4 to NA) | 53.8 (32.6 to NA) | 53.8 (38.4 to NA) |
| From first dose of rituximab SC | NA (32.7 to NA) | 45.5 (25.1 to NA) | 45.5 (33.5 to NA) |
PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.
| Months | DLBCL Arm | FL Arm | Overall Population |
|---|---|---|---|
| From first dose of rituximab IV | NA (33.4 to NA) | 53.8 (32.6 to NA) | 53.8 (38.4 to NA) |
| From first dose of rituximab SC | NA (32.7 to NA) | 45.5 (25.1 to NA) | 44.5 (35.5 to NA) |
OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.
| Months | DLBCL Arm | FL Arm | Overall Population |
|---|---|---|---|
| From first dose of rituximab IV | 51.4 (50.4 to NA) | NA (NA to NA) | NA (NA to NA) |
| From first dose of rituximab SC | 51.4 (50.4 to NA) | NA (NA to NA) | NA (NA to NA) |
DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.
| Months | DLBCL Arm | FL Arm | Overall Population |
|---|---|---|---|
| Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria | NA (NA to NA) | NA (19.7 to NA) | NA (32.7 to NA) |
CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999).
| Percentage | DLBCL Arm | FL Arm | Overall Population |
|---|---|---|---|
| Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria | 74.2 (63.8 to 82.9) | 76.5 (50.1 to 93.2) | 74.5 (65.1 to 82.5) |
Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report
No measurements were reported for this outcome.
The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range. For each domain was scored using the following formula: Domain score = \[(Sum of completed item (question) responses / Number of completed items) - 1\] x 100 / (Maximum possible item response value - Minimum possible item response value) The final RASQ domains is calculated using the formula: RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants.
| Scores on a Scale | DLBCL Arm | FL Arm | Overall Population |
|---|---|---|---|
| Patient-Reported Rituximab Administration Questionnaire (RASQ) Score | 70.5 ± 20.76 | 69.2 ± 19.83 | 70.2 ± 20.48 |
Collected over From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months]). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DLBCL Arm | 22/95 (23.2%) | 11/95 (11.6%) | 58/95 (61.1%) |
| FL Arm | 5/27 (18.5%) | 8/27 (29.6%) | 12/27 (44.4%) |
| Event | DLBCL Arm | FL Arm |
|---|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/95 | 2/27 |
| Cardiac Failure AcuteCardiac disorders | 0/95 | 1/27 |
| GoitreEndocrine disorders | 0/95 | 1/27 |
| DeathGeneral disorders | 2/95 | 1/27 |
| Abscess LimbInfections and infestations | 0/95 | 1/27 |
| Candida InfectionInfections and infestations | 0/95 | 1/27 |
| Klebsiella BacteraemiaInfections and infestations | 0/95 | 1/27 |
| Septic ShockInfections and infestations | 0/95 | 1/27 |
| Fibula FractureInjury, poisoning and procedural complications | 0/95 | 1/27 |
| Liver Function Test AbnormalInvestigations | 0/95 | 1/27 |
| Event | DLBCL Arm | FL Arm |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 41/95 | 7/27 |
| ParaesthesiaNervous system disorders | 14/95 | 5/27 |
| AnaemiaBlood and lymphatic system disorders | 13/95 | 4/27 |
| LeukopeniaBlood and lymphatic system disorders | 10/95 | 1/27 |
| Mucosal InflammationGeneral disorders | 10/95 | 2/27 |
| ThrombocytopeniaBlood and lymphatic system disorders | 9/95 | 2/27 |
| DiarrhoeaGastrointestinal disorders | 8/95 | 0/27 |
| Injection Site ErythemaGeneral disorders | 5/95 | 2/27 |
| Aspartate Aminotransferase IncreasedInvestigations | 0/95 | 2/27 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/95 | 2/27 |
| Age, Continuous(Years) | DLBCL Arm | FL Arm | Total |
|---|---|---|---|
| Mean | 51.3 ± 13.78 | 52.8 ± 12.65 | 51.7 ± 13.48 |
| Sex: Female, Male(Participants) | DLBCL Arm | FL Arm | Total |
|---|---|---|---|
| Female | 56 | 22 | 78 |
| Male | 49 | 12 | 61 |
| Race/Ethnicity, Customized(Participants) | DLBCL Arm | FL Arm | Total |
|---|---|---|---|
| Not Hispanic or Latino | 15 | 4 | 19 |
| Hispanic or Latino | 0 | 0 | 0 |
| Other | 74 | 24 | 98 |
| Not applicable as per local regulations | 16 | 6 | 22 |
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Studies of the drug tested here: Rituximab