An observational study in Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma, sponsored by Hoffmann-La Roche. Completed at 5 sites in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-22.
Sponsored by Hoffmann-La Roche · Observational
Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 154 is above the median of 136 across 625 observational studies indexed under Lymphoma.
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Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with aggressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma [DLBCL])
Exclusion Criteria:
Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
Drug: Cyclophosphamide · Drug: Hydroxydaunorubicin · Drug: Oncovin · Drug: Prednisone · Drug: Rituximab
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Also known as: MabThera
Probability of Event Free Survival (EFS)
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
Time frame: Up to 41 months
Percentage of Participants Who Were Alive
Percentage of participants with survival was calculated 41 months after the first dose of study treatment.
Time frame: Up to 41 months
| Milestone | Diffuse Large B-Cell Lymphoma |
|---|---|
| Started | 154 |
| Started induction therapy | 151 |
| Completed | 104 |
| Not completed | 50 |
| Withdrew: Not started induction therapy | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 15 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Lost to follow-up | 26 |
| Withdrew: Other | 2 |
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
| probability of EFS | Diffuse Large B-Cell Lymphoma |
|---|---|
| Probability of Event Free Survival (EFS) | 0.695 (0.607 to 0.796) |
Percentage of participants with survival was calculated 41 months after the first dose of study treatment.
| percentage of participants | Diffuse Large B-Cell Lymphoma |
|---|---|
| Percentage of Participants Who Were Alive | 74.4 |
Collected over 41 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | — | 25/151 (16.6%) | 14/151 (9.3%) |
| Event | Diffuse Large B-Cell Lymphoma |
|---|---|
| Disease progressionGeneral disorders | 11/151 |
| Disease recurrenceGeneral disorders | 3/151 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/151 |
| Herpes zosterInfections and infestations | 1/151 |
| PeritonitisInfections and infestations | 1/151 |
| PneumoniaInfections and infestations | 1/151 |
| AnaemiaBlood and lymphatic system disorders | 1/151 |
| HaematotoxicityBlood and lymphatic system disorders | 1/151 |
| LeukopeniaBlood and lymphatic system disorders | 1/151 |
| NeutropeniaBlood and lymphatic system disorders | 1/151 |
| Event | Diffuse Large B-Cell Lymphoma |
|---|---|
| NauseaGastrointestinal disorders | 5/151 |
| NeutropeniaBlood and lymphatic system disorders | 2/151 |
| VomitingGastrointestinal disorders | 2/151 |
| Infusion related reactionInjury, poisoning and procedural complications | 2/151 |
| HeadacheNervous system disorders | 1/151 |
| Eye swellingEye disorders | 1/151 |
| ArrhythmiaCardiac disorders | 1/151 |
| DiarrhoeaGastrointestinal disorders | 1/151 |
| ProctalgiaGastrointestinal disorders | 1/151 |
| ChillsGeneral disorders | 1/151 |
Full analysis population included all participants enrolled in the study and who started induction therapy.
| Age, Continuous(years) | Diffuse Large B-Cell Lymphoma |
|---|---|
| Median | 58 (19 to 83) |
| Sex: Female, Male(Participants) | Diffuse Large B-Cell Lymphoma |
|---|---|
| Female | 61 |
| Male | 90 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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