Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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.

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Hydroxydaunorubicin

Oncovin

Clinical Trials

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.

MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

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.

Percentage of participants with survival was calculated 41 months after the first dose of study treatment.

Serbian Lymphoma Group

Hoffmann-La Roche

Participants, who were not treated previously for DLBCL, and received rituximab in combination with 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 were 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.

Age, Continuous

Sex: Female, Male

Full analysis population included all participants enrolled in the study and who started induction therapy.

Medical Communications

Probability of Event Free Survival (EFS)

Percentage of Participants Who Were Alive

Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received 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 were 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.

Overall Study

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Peripheral T-cell Lymphoma

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Nivolumab

Etoposide

Prednisolone

Etoposide phosphate

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Immune Checkpoint Inhibitors

Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.

Nivolumab injection is to be administered as an IV infusion.

Dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using the Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a \>10% weight gain or loss. Patients receive six 21-day cycles of the medications.

Brad Haverkos, MD

This regimen aims to become the first line treatment for peripheral T cell lymphoma, using nivolumab with the standard of care chemotherapy.

Patients in this study will receive nivolumab in combination with the standard of care dose-adjusted EPOCH (etoposide, prednisone, vincristine, doxorubicin, cyclophosphamide) for six 21 day cycles. Patients will then have an autologous stem cell transplant or continue to receive maintenance therapy with nivolumab.

Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas

Nivolumab With Standard of Care Chemotherapy for the First Line Treatment of Peripheral T Cell Lymphoma

Toxicity analysis of nivolumab will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 and relationship to study drug or the amount of grade 4-5 non-hematologic toxicities.

Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.

PFS will be descriptive in nature (no formal statistical analyses will be conducted).

This will be descriptive in nature (no formal statistical analyses will be conducted).

Bristol-Myers Squibb

University of Colorado, Denver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma	NCT02486952	Lymphoma, Lymph...	Cyclophosphamid... Hydroxydaunorub... Oncovin Prednisone Rituximab	18 Years -	Hoffmann-La Roche
Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas	NCT03586999	Peripheral T Ce...	Nivolumab Etoposide Prednisolone Oncovin Cyclophosphamid... Hydroxydaunorub...	18 Years - 80 Years	University of Colorado, Denver

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