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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00052936
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Universität des Saarlandes ( German High-Grade Non-Hodgkin's Lymphoma Study Group )

Study Description
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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).


Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: rituximab Drug: CHOP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1506 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2001
Actual Primary Completion Date : August 5, 2010
Actual Study Completion Date : August 5, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Steroids
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: S6
6x CHOP-14
 Biological: filgrastim
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
36Gy on BULK and extranodal involvement
Experimental: R6
6x CHOP-14 + 8x Rituximab
 Biological: filgrastim
Biological: rituximab
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
36Gy on BULK and extranodal involvement
Experimental: S8
8x CHOP-14
 Biological: filgrastim
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
36Gy on BULK and extranodal involvement
Experimental: R8
8x CHOP-14 + 8x Rituximab
 Biological: filgrastim
Biological: rituximab
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
36Gy on BULK and extranodal involvement


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Complete response rate at 3 years within the study and then periodically after study completion [ Time Frame: 3 years within the study and then periodically after ]
  2. Progression rate [ Time Frame: 3 years within the study and then periodically after ]
  3. Survival [ Time Frame: 3 years within the study and then periodically after ]
  4. Tumor control [ Time Frame: 3 years within the study and then periodically after ]
  5. Disease-free survival [ Time Frame: 3 years within the study and then periodically after ]

Eligibility Criteria
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Ages Eligible for Study:   61 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052936


Locations
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Sponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Investigators
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Study Chair: Michael G.M. Pfreundschuh, MD Universitaetsklinikum des Saarlandes
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: German High-Grade Non-Hodgkin's Lymphoma Study Group
ClinicalTrials.gov Identifier: NCT00052936    
Other Study ID Numbers: CDR0000269015
DSHNHL-1999-1A ( Other Grant/Funding Number: Deutsche Krebshilfe )
EU-20243 ( Other Identifier: Ethikkommission der Ärztekammer des Saarlandes [85/99] )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Keywords provided by Universität des Saarlandes ( German High-Grade Non-Hodgkin's Lymphoma Study Group ):
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids