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Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

filgrastim

rituximab

CHOP regimen

cyclophosphamide

doxorubicin hydrochloride

prednisone

vincristine sulfate

radiation therapy

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, stage III grade 1 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III grade 2 follicular lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage I adult Burkitt lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma

Eligibility Criteria

61 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement) CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed B-cell NHL including the following: Stage III follicular lymphoma Stage III follicular lymphoma and diffuse B-cell lymphoma Lymphoblastic precursor B-cell lymphoma Diffuse large cell B-cell lymphoma Centroblastic Immunoblastic Plasmablastic Anaplastic large cell T-cell-rich B-cell lymphoma Primary effusion lymphoma Intravasal B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle zone lymphoma, blastoid Burkitt's lymphoma Burkitt-like lymphoma Aggressive marginal zone lymphoma (monocytoid) T-cell NHL including the following: Lymphoblastic precursor T-cell lymphoma Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS) Lennert's lymphoma T-zone lymphoma T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type Anaplastic large cell lymphoma ALK^+ ALK^- Extranodal NK/T-cell lymphoma, nasal type Intestinal T/NK-cell lymphoma (with or without enteropathy) Hepatosplenic gamma-delta lymphoma Subcutaneous panniculitis-like PTCL Aggressive T/NK PTCL Anaplastic large-cell NHL, NOS Bone marrow involvement no more than 25% No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract PATIENT CHARACTERISTICS: Age 61 to 80 Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC at least 2,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) No active hepatitis infection Renal Creatinine no greater than 2 times ULN Cardiovascular No Canadian Cardiovascular Society class III or IV angina pectoris No New York Heart Association class III or IV cardiac failure Ejection fraction at least 50% Fractional shortenings at least 25% by echocardiography or nuclear medicine examination Pulmonary FEV1 at least 50% Diffusion capacity at least 50% Other No uncontrolled diabetes mellitus No known hypersensitivity to any study medications No other concurrent malignancy HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery Not specified Other Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study) No other concurrent lymphoma therapy No concurrent participation in another treatment study

Sites / Locations

Haematologisch Onkologische Praxis
Klinikum St. Marien
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
II. Medizinische Klinik
Specialist Practice for Oncology
Haematologische Praxis
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Klinikum Augsburg
Kreiskrankenhaus Aurich
Regional Hospital Bad Hersfeld
Humaine - Clinic
Krankenhaus Hohe Warte Mediziniche Klinik
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Haematologisch-Onkologische Schwerpunktpraxis
Hospital Complex Bernburg
Krankenhaus Bietigheim
Saint Agnes Hospital
Saint Josef Hospital
Knappschaft Krankenhaus
Medizinische Poliklinik
Rheinische Friedrich-Wilhelms-Universitat
DIAKO Ev. Diakonie Krankenhaus gGmbH
Medizinische Klinik Am Lukas - Krankenhaus
General Hospital
Hospital Kuchwald Chemnitz
Lung Clinic Cologne-Merheim
Praxis Fuer Haematologie Internistische Onkologie
Medizinische Universitaetsklinik I at the University of Cologne
Carl - Thiem - Klinkum Cottbus
Klinikum Darmstadt
Saint Johannes Hospital Dortmund
Universitatsklinikum Carl Gustav Carus
St. Johannes Hospital - Medical Klinik II
Franz Hospital Dulmen
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
Hans - Susemihl - Krankenhaus
Klinikum Erfurt
St. Antonius Hospital
Universitaetsklinikum Essen
Klinikum Frankfurt (Oder) GmbH
Krankenhaus Nordwest
Evang. Deaconess Hospital Freiburg
Municipal Hospital Complex
Robert - Koch Hospital
Centre for Internal Medicine Gieben
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Staedtisches Klinikum Guetersloh
Universitaetsklinikum Goettingen
Allgemeines Krankenhaus Hagen
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Krankenhaus St. Elisabeth und St. Barbara
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Universitaetsklinikum Halle
University Medical Center Hamburg - Eppendorf
Asklepios Klinik Nord Heidberg
Allgemeines Krankenhaus Altona
Haematologisch-Onkologische Praxis Altona
Evangelische Krankenhaus Hamm
Henriettenstiftung Krankenhaus
Krankenhaus Siloah - Medizinische Klinik II
Medizinische Hochschule Hannover
Oncology Specialists Clinic
Thoraxklinik Heidelberg
Medizinische Universitaetsklinik und Poliklinik
Regional Hospital Heidenheim
Regional Hospital Am Plattenwald - Bad Friedrichshall
Klinikum Herford
Marienhospital at Ruhr University Bochum
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Onkologische Schwerpunktpraxis
Evang. Hospital
Medical University Hospital Homburg
Hospital Complex Hoyerswerda
Gemeinschaftspraxis Innere Medizin
Klinikum der Friedrich-Schiller Universitaet Jena
Municipal Hospital Complex of the University
Staedtisches Klinikum Karlsruhe gGmbH
Red Cross Hospital Kassel
Staedtisches Krankenhaus Kiel
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
Praxis fuer Haematologie und Onkologie
Leonardis Clinic
Klinikum Krefeld GmbH
Frankenwald Klinik
Caritas - Krakenhaus Lebach
University Leipzig Clinic of Internal Medicine
Klinikum "St. Georg" Leipzig
Klinikum Lippe - Lemgo
St. Vincenz Hospital Limburg
St. Bonifatius Hospital Lingen
Dreifaltigkeits Hospital
Klinikum Ludwigsburg
St. Marien Hospital Ludwighafen
Municipal Complex of Ludwigshafen
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Staedtisches Klinikum Magdeburg - Altstadt
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Johannes Gutenberg University
III Medizinische Klinik Mannheim
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Regional Hospital Mayen
Klinikum Minden
Ev. Hospital Bethesda
Hospital Maria-Hilf II
Evangelisches Krankenhaus - Mulheim
St. Marien Hospital - Muelheim an der Ruhr
Kreiskrankenhaus Muenchberg
Munich Oncologic Practice at Elisenhof
Klinikum der Universitaet Muenchen - Innenstadt Campus
Krankenhaus Muenchen Schwabing
Klinikum der Universitaet Muenchen - Grosshadern Campus
Municipal Hospital Munich
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Regional Hospital Neumarkt
Staedtisches Klinikum Neunkirchen gGmbH
Lukaskrankenhaus Neuss
Klinikum Nuernberg - Klinikum Nord
Klinikum Offenburg
Hematologische Praxis
Ev. Hospital Oldenburg
Klinikum Oldenburg
Paracelsus - Klinik Osnabrueck
Municipal Hospital Complex
Klinikum Ernst Von Bergmann
Kreiskrankenhaus Radebeul
Krankenhaus St. Elisabeth - Ravensburg
Klinikum der Universitaet Regensburg
Hematologische Onkologische Praxis
Krankenhaus Barmherzige Brueder Regensburg
Jakobi Krankenhaus
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
Caritasklinik St. Theresia
Schwerpunktpraxis fuer Haematologie und Onkologie
St. Elizabeth-Klinik Saarlouis
Martin - Luther Hospital
Deaconess Hospital
Leopoldina - Krankenhaus
Evang. Jung-Stilling Hospital
St. Lukas - Clinic Solingen
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Diakonie Klinikum Stuttgart
Klinikum Stuttgart - Buergerhospital
Hospital Bad Cannstatt
Robert-Bosch-Krankenhaus
St. Elisabeth Hospital Thuine
Regional Hospital Traunstein
Krankenanstalt Mutterhaus der Borromaerinnen
Krankenhaus Barmherzigen Brueder
Hospital Tutzing
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ev. Hospital Unna
St. Marienhospital - Vechta
Municipal Hospital Complex
Regional Hospital Waldbrol
Evangelisches Krankenhaus Essen Werden
Hospital Wetzler
Deutsche Klinik fuer Diagnostik
Dr. Horst-Schmidt-Kliniken
Ev. Hospital Witten-Herdecke
Kliniken St. Antonius
University Wurzburg
Municipal Hospital Complex Zwickau
City Hospital Triemli
UniversitaetsSpital Zuerich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

6x CHOP-14

6x CHOP-14 + 8x Rituximab

8x CHOP-14

8x CHOP-14 + 8x Rituximab

Outcomes

Primary Outcome Measures

Time to treatment failure at 3 years within the study and then periodically after study completion

Secondary Outcome Measures

Complete response rate at 3 years within the study and then periodically after study completion

Progression rate

Survival

Tumor control

Disease-free survival

Full Information

NCT ID

NCT00052936

First Posted

January 24, 2003

Last Updated

May 14, 2021

Sponsor

German High-Grade Non-Hodgkin's Lymphoma Study Group

1. Study Identification

Unique Protocol Identification Number

NCT00052936

Brief Title

Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

Official Title

Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Years With Aggressive Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

August 5, 2010 (Actual)

Study Completion Date

August 5, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

German High-Grade Non-Hodgkin's Lymphoma Study Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).

Detailed Description

OBJECTIVES: Primary Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with vs without rituximab in elderly patients with aggressive non-Hodgkin's lymphoma. Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with these regimens. Compare the rate of complete remission, rate of primary progression, tumor control, disease-free survival, overall survival, and relapse after radiotherapy in patients treated with these regimens. Compare the safety and side effects of these regimens in these patients. Secondary Compare short-term and long-term side effects of these regimens in these patients. Compare quality of life of patients treated with these regimens. Compare the cost of these regimens in these patients. Determine relapse in patients treated with these regimens who received involved-field radiotherapy. OUTLINE: This is a randomized (randomized part of study completed as of 6/2005), open-label, multicenter study. Patients are stratified according to participating center, value for serum lactic dehydrogenase (no greater than upper limit of normal [ULN] vs greater than ULN), bulky disease present (no vs yes), stage (I or II vs III or IV), general ECOG status of patient (0 or 1 vs 2), and age (61 to 70 vs 71-80). Patients are randomized to 1 of 4 treatment arms. Patients with CD20-negative lymphoma are randomized to arms I or II only. Prephase treatment:Patients receive vincristine IV on day -6 and prednisone on day -6 to day 0 before initiating CHOP chemotherapy. Arm I (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-12 of each CHOP course. Treatment repeats every 2 weeks for 6 courses. Arm II (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy and G-CSF as in arm I for a total of 8 courses. Arm III: Patients receive standard CHOP chemotherapy and G-CSF as in arm I. Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses. Arm IV (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy and G-CSF as in arm II. Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of the last chemotherapy course, after complete recovery of bone marrow, and after complete remision of mucositis, patients with sites of initial bulky disease or extranodal involvement undergo radiotherapy 5 times a week for 4 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 1580 patients will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, stage III grade 1 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III grade 2 follicular lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage I adult Burkitt lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1506 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

6x CHOP-14

Arm Title

Arm Type

Experimental

Arm Description

6x CHOP-14 + 8x Rituximab

Arm Title

Arm Type

Experimental

Arm Description

8x CHOP-14

Arm Title

Arm Type

Experimental

Arm Description

8x CHOP-14 + 8x Rituximab

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Biological

Intervention Name(s)

rituximab

Intervention Type

Drug

Intervention Name(s)

CHOP regimen

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

36Gy on BULK and extranodal involvement

Primary Outcome Measure Information:

Title

Time to treatment failure at 3 years within the study and then periodically after study completion

Time Frame

3 years within the study and then periodically after study completion

Secondary Outcome Measure Information:

Title

Complete response rate at 3 years within the study and then periodically after study completion

Time Frame