Rituximab and Combination Chemotherapy With or Without Ra... | NCT00278408

NCT00278408

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

OBJECTIVES:

Primary

Compare the time to treatment failure in patients with previously untreated, low-risk, aggressive, B-cell non-Hodgkin's lymphoma treated with 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone with vs without radiotherapy.

Secondary

Compare the time to progression in patients treated with these regimens.
Compare the overall and disease-free/relapse-free survival of patients treated with these regimens.
Compare the complete response rate in patients treated with these regimens.
Compare the tumor control in patients treated with these regimens.
Compare the safety of these regimens in these patients.
Compare the pharmacoeconomics of these regimens.
Compare patient adherence to these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to study center, serum lactic dehydrogenase level (≤ upper limit of normal [ULN] vs > ULN), disease stage (I or II vs III or IV), ECOG performance status (0-1 vs 2-3), bulky disease, and extranodal involvement. Patients with initial bulky disease and/or qualifying extranodal involvement are randomized to 1 of 4 treatment arms. Patients with non-bulky disease are randomized to treatment arms I or III.

All patients will be given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.

Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.
Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.

Patients in all arms undergo restaging of their disease after courses 3 and 6 of R-CHOP. Patients with stable disease after 6 courses or disease progression after courses 3 or 6 proceed to salvage chemotherapy off study. Patients achieving a partial remission or an unconfirmed CR after 6 courses undergo additional restaging 4 weeks later. Patients with disease progression proceed to salvage chemotherapy off study. Patients who achieve CR after 6 courses of R-CHOP or have a confirmed CR after the additional restaging undergo radiotherapy according to randomization (as above).

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,072 patients will be accrued for this study.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional: 6 R-CHOP-21	Active Comparator	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate
Interventional: 6 R-CHOP-21 + radiotherapy	Active Comparator	Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.	Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy
Interventional: 6 R-CHOP-14	Active Comparator	Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate

Name	Type	Description	Arm Group Labels	Other Names
filgrastim	Biological		Interventional: 6 R-CHOP-14 Interventional: 6 R-CHOP-14 and radiotherapy
rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 Years Event-free Survival	Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.	Each patient will be observed for 3 years starting from completion of treatment.

Secondary Outcomes

Measure	Description	Time Frame
3 Years Progression-free Survival	Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline.	Each patient will be observed for 3 years starting from completion of treatment.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Michael G.M. Pfreundschuh, MD †	Universitaetsklinikum des Saarlandes	Study Chair
Viola Poeschel, MD	Study Office Homburg	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Department of Hematology		Copenhagen			Denmark
Amtssygehuset i Herlev

References Module

Citations

PubMed Identifier	Type	Citation
	Result	Radiotherapy (RT) to bulky (B) and extralymphatic (E) disease in combination with 6xR-CHOP-14 or R-CHOP-21 in young good-prognosis DLBCL patients: Results of the 2x2 randomized UNFOLDER trial of the DSHNHL/GLA. Michael Pfreundschuh, Niels Murawski, Marita Ziepert, Bettina Altmann, Martin H. Dreyling, Peter Borchmann, Stefano Luminari, Mathias Witzens-Harig, Judith Dierlamm, Mathias Haenel, Lorenz Truemper, Bernd Metzner, Eva Lengfelder, Ulrich B. Keller, Christian Ruebe, Christian Berdel, Norbert Schmitz, Gerhard Held, and Viola Poeschel Journal of Clinical Oncology 2018 36:15_suppl, 7574-7574
	Result	Role of radiotherapy and dose-densification of R-CHOP in primary mediastinal B-cell lymphoma: A subgroup analysis of the unfolder trial of the German Lymphoma Alliance (GLA). Gerhard Held, Lorenz Thurner, Viola Poeschel, Christian Berdel, German Ott, Christian Schmidt, Andreas Viardot, Peter Borchmann, Ofer Shpilberg, Maike Nickelsen, Massimo Federico, Peter de Nully Brown, Niels Murawski, Lorenz H. Trumper, Heinz Schmidberger, Christian Ruebe, Jochen Fleckenstein, Norbert Schmitz, Markus Loeffler, Marita Ziepert, and German Lymphoma Alliance Journal of Clinical Oncology 2020 38:15_suppl, 8041-8041
37427146

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Feb 25, 2013

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

stage IV adult diffuse mixed cell lymphoma

nodal marginal zone B-cell lymphoma

anaplastic large cell lymphoma

contiguous stage II adult immunoblastic large cell lymphoma

noncontiguous stage II adult immunoblastic large cell lymphoma

stage I adult immunoblastic large cell lymphoma

stage III adult immunoblastic large cell lymphoma

stage IV adult immunoblastic large cell lymphoma

contiguous stage II adult Burkitt lymphoma

contiguous stage II mantle cell lymphoma

noncontiguous stage II adult Burkitt lymphoma

noncontiguous stage II mantle cell lymphoma

stage I adult Burkitt lymphoma

stage I mantle cell lymphoma

stage III adult Burkitt lymphoma

stage III mantle cell lymphoma

stage IV adult Burkitt lymphoma

stage IV mantle cell lymphoma

contiguous stage II marginal zone lymphoma

noncontiguous stage II marginal zone lymphoma

stage I marginal zone lymphoma

stage III marginal zone lymphoma

stage IV marginal zone lymphoma

Masking Info

700 patients were randomized, however 695 were analyzed due to a withdrawal of consent (5 patients)

Arm/Group Information

ID	Title	Description
BG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
BG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
BG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
BG003	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication	Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
BG004	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication	Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
BG005	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication	Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00081 ParticipantsBG00181 ParticipantsBG002155 ParticipantsBG003

Age, Continuous

Median

Full Range

years

Title	Denominators	Categories
	ParticipantsBG00081 ParticipantsBG00181 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00081 ParticipantsBG00181 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

3 Years Event-free Survival

Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG003	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication	Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG004	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication	Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG005	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication	Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim

Units	Counts
Participants	OG00081 OG00181 OG002155 OG003

Title

Denominators

Categories

Title	Measurements
	OG00051 OG00156 OG002126 OG003

Secondary

3 Years Progression-free Survival

Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline.

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002

Secondary

3 Years Overall Survival

Overall survival was defined as the time from randomization to death of any cause.

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication

Secondary

Rate of Complete Remissions and Progressive Disease

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate

Secondary

Number of Patients With a Relapse After a CR/CRu

Relapse is defined as, recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or a marked increase in lymphoma manifestation size by more thyn 25% after at least 2 months CR or CRu from the time point of the final restaging examination

Only patients who reached a CR/CRu after at least 2 months after the final restaging examination were taken for the relapse analysis.

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim

Secondary

Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin)

The number analyzed differs from overall number analyzed due to missing data.

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002

Secondary

Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median)

Posted

Median

Full Range

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate

Secondary

Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion

The number analyzed differs from overall number analyzed due to missing data.

Posted

Count of Participants

Participants

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002

Secondary

Adherence to Protocol - Total Duration of Chemotherapy in Days (Median)

Posted

Median

Full Range

days

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate

Secondary

Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median)

Posted

Median

Full Range

mg/m²

Each patient will be observed for 3 years starting from completion of treatment.

ID	Title	Description
OG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate
OG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
OG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	7	81	17	81	49	81
EG001	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication	Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	7	81	17	81	58	81
EG002	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	15	155	43	155	98	155
EG003	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication	Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	11	150	41	150	82	150
EG004	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication	Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	10	114	30	114	41	114
EG005	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication	Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	11	114	27	114	65	114

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Life-threatening infections	Infections and infestations	Systematic Assessment	EG0002 events2 affected81 at risk EG0010 events0 affected81 at risk EG0021 events1 affected155 at risk EG0032 events2 affected150 at risk EG0040 events0 affected114 at risk EG0050 events0 affected114 at risk
Severe Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 events0 affected81 at risk EG0010 events0 affected81 at risk EG0020 events0 affected155 at risk EG003
secondary neoplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0004 affected81 at risk EG0011 affected81 at risk EG0027 affected155 at risk EG003
unplanned hospitalisation (emergency case)	General disorders	Systematic Assessment	EG00014 events10 affected81 at risk EG00117 events14 affected81 at risk EG00236 events28 affected155 at risk EG003
other	General disorders	Systematic Assessment	EG0002 events1 affected81 at risk EG0012 events2 affected81 at risk EG0027 events7 affected155 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Nausea CTC 3-5	Gastrointestinal disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0001 affected75 at risk EG0015 affected75 at risk EG0027 affected148 at risk EG0035 affected138 at risk EG004
Vomiting CTC 3-5	Gastrointestinal disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0001 affected74 at risk EG0013 affected75 at risk EG0024 affected148 at risk EG003
Diarrhoe CTC 3-5	Gastrointestinal disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0000 affected76 at risk EG0011 affected75 at risk EG0022 affected149 at risk EG003
Arrhythmia CTC 3-5	Cardiac disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0000 affected75 at risk EG0010 affected74 at risk EG0020 affected149 at risk EG003
Cardiac functions CTC 3-5	Cardiac disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0000 affected73 at risk EG0010 affected72 at risk EG0021 affected149 at risk EG003
Sensory CTC 3-5	Nervous system disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0003 affected75 at risk EG0014 affected76 at risk EG00210 affected150 at risk EG003
Infection CTC 3-5	Infections and infestations	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0006 affected79 at risk EG00112 affected78 at risk EG00213 affected152 at risk EG003
Constipation CTC 3-5	Gastrointestinal disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0001 affected75 at risk EG0010 affected74 at risk EG0022 affected148 at risk EG003
Mucositis CTC 3-5	Infections and infestations	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0000 affected76 at risk EG0011 affected75 at risk EG0020 affected149 at risk EG003
Mood CTC 3-5	Psychiatric disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0000 affected74 at risk EG0010 affected75 at risk EG0021 affected148 at risk EG003
Allergy CTC 3-5	Immune system disorders	Systematic Assessment	due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk	EG0002 affected75 at risk EG0014 affected75 at risk EG0021 affected149 at risk EG003
Leukocytopenia CTC 3, 4	Blood and lymphatic system disorders	Systematic Assessment		EG00031 affected43 at risk EG00122 affected44 at risk EG00245 affected76 at risk EG003
Thrombocytopenia CTC 3, 4	Blood and lymphatic system disorders	Systematic Assessment		EG0003 affected76 at risk EG0013 affected75 at risk EG0023 affected142 at risk EG003
Anemia CTC 3, 4	Blood and lymphatic system disorders	Systematic Assessment		EG0001 affected76 at risk EG0013 affected76 at risk EG0029 affected145 at risk EG003

ID	Term
D008223	Lymphoma
D008224	Lymphoma, Follicular
D016403	Lymphoma, Large B-Cell, Diffuse
D008228	Lymphoma, Non-Hodgkin
D018442	Lymphoma, B-Cell, Marginal Zone
D017728	Lymphoma, Large-Cell, Anaplastic
D016400	Lymphoma, Large-Cell, Immunoblastic
D002051	Burkitt Lymphoma
D020522	Lymphoma, Mantle-Cell

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016393	Lymphoma, B-Cell
D016399	Lymphoma, T-Cell
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D014412	Tumor Virus Infections

ID	Term
D000069585	Filgrastim
D000069283	Rituximab
D003520	Cyclophosphamide
D004317	Doxorubicin
D011241	Prednisone
D014750	Vincristine
D011878	Radiotherapy

Ancestor Terms

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D012712	Serum Globulins
D005916	Globulins
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D013812	Therapeutics

ParticipantsBG004114

ParticipantsBG005114

ParticipantsBG006695

ParticipantsBG003150

ParticipantsBG004114

ParticipantsBG005114

ParticipantsBG006695

ParticipantsBG003150

ParticipantsBG004114

ParticipantsBG005114

ParticipantsBG006695

Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.

rituximab

cyclophosphamide

doxorubicin hydrochloride

prednisone

vincristine sulfate

EG0040 events0 affected114 at risk

EG0050 events0 affected114 at risk

EG0048 affected114 at risk

EG0058 affected114 at risk

EG00420 events17 affected114 at risk

EG00525 events16 affected114 at risk

EG0045 events5 affected114 at risk

EG0053 events3 affected114 at risk

EG0053 affected112 at risk

EG0042 affected105 at risk

EG0051 affected112 at risk

EG0040 affected105 at risk

EG0051 affected112 at risk

EG0042 affected105 at risk

EG0050 affected112 at risk

EG0040 affected105 at risk

EG0050 affected112 at risk

EG0043 affected103 at risk

EG0058 affected111 at risk

EG0048 affected105 at risk

EG00512 affected113 at risk

EG0040 affected105 at risk

EG0052 affected112 at risk

EG0040 affected105 at risk

EG0053 affected112 at risk

EG0040 affected105 at risk

EG0051 affected112 at risk

EG0040 affected105 at risk

EG0051 affected113 at risk

EG00421 affected49 at risk

EG00521 affected55 at risk

EG0042 affected99 at risk

EG0051 affected103 at risk

EG0042 affected100 at risk

EG00511 affected104 at risk

ParticipantsOG005103

ParticipantsOG004100

ParticipantsOG005104

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004103

ParticipantsOG005111

ParticipantsOG004105

ParticipantsOG005112

ParticipantsOG004105

ParticipantsOG005113

ParticipantsOG004105

ParticipantsOG005113

OG0043000(1000 to 6000)

OG0053000(500 to 4000)

ParticipantsOG004105

ParticipantsOG005113

OG0042242(682 to 2520)

OG0052228(389 to 2471)

ID	Type	Description	Link
DSHNHL-2004-3
EUDRACT-2005-005218-19
EU-205111