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NCT00052936 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-05-18

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
80 Years
minimum Age
61 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    6x CHOP-14
    intervention Names
    1. Biological: filgrastim
    2. Drug: CHOP regimen
    3. Drug: cyclophosphamide
    4. Drug: doxorubicin hydrochloride
    5. Drug: prednisone
    6. Drug: vincristine sulfate
    7. Radiation: radiation therapy
    label
    S6
    type
    EXPERIMENTAL
  2. description
    6x CHOP-14 + 8x Rituximab
    intervention Names
    1. Biological: filgrastim
    2. Biological: rituximab
    3. Drug: CHOP regimen
    4. Drug: cyclophosphamide
    5. Drug: doxorubicin hydrochloride
    6. Drug: prednisone
    7. Drug: vincristine sulfate
    8. Radiation: radiation therapy
    label
    R6
    type
    EXPERIMENTAL
  3. description
    8x CHOP-14
    intervention Names
    1. Biological: filgrastim
    2. Drug: CHOP regimen
    3. Drug: cyclophosphamide
    4. Drug: doxorubicin hydrochloride
    5. Drug: prednisone
    6. Drug: vincristine sulfate
    7. Radiation: radiation therapy
    label
    S8
    type
    EXPERIMENTAL
  4. description
    8x CHOP-14 + 8x Rituximab
    intervention Names
    1. Biological: filgrastim
    2. Biological: rituximab
    3. Drug: CHOP regimen
    4. Drug: cyclophosphamide
    5. Drug: doxorubicin hydrochloride
    6. Drug: prednisone
    7. Drug: vincristine sulfate
    8. Radiation: radiation therapy
    label
    R8
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    name
    filgrastim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. R6
    2. R8
    name
    rituximab
    type
    BIOLOGICAL
  3. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    name
    CHOP regimen
    type
    DRUG
  4. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    name
    cyclophosphamide
    type
    DRUG
  5. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    name
    doxorubicin hydrochloride
    type
    DRUG
  6. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    name
    prednisone
    type
    DRUG
  7. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    name
    vincristine sulfate
    type
    DRUG
  8. arm Group Labels
    1. R6
    2. R8
    3. S6
    4. S8
    description
    36Gy on BULK and extranodal involvement
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
FACTORIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1506
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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 Outcomes
  1. measure
    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. measure
    Progression rate
    time Frame
    3 years within the study and then periodically after
  3. measure
    Survival
    time Frame
    3 years within the study and then periodically after
  4. measure
    Tumor control
    time Frame
    3 years within the study and then periodically after
  5. measure
    Disease-free survival
    time Frame
    3 years within the study and then periodically after
Full 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.
Source references
references
  1. citation
    Pfreundschuh M, Schubert J, Ziepert M, Schmits R, Mohren M, Lengfelder E, Reiser M, Nickenig C, Clemens M, Peter N, Bokemeyer C, Eimermacher H, Ho A, Hoffmann M, Mertelsmann R, Trumper L, Balleisen L, Liersch R, Metzner B, Hartmann F, Glass B, Poeschel V, Schmitz N, Ruebe C, Feller AC, Loeffler M; German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol. 2008 Feb;9(2):105-16. doi: 10.1016/S1470-2045(08)70002-0. Epub 2008 Jan 15.
    pmid
    18226581
    type
    RESULT
  2. citation
    Christofyllakis K, Kaddu-Mulindwa D, Lesan V, Rixecker T, Kos IA, Held G, Regitz E, Pfreundschuh M, Bittenbring JT, Thurner L, Poeschel V, Ziepert M, Altmann B, Bewarder M. An inherited genetic variant of the CEP72 gene is associated with the development of vincristine-induced peripheral neuropathy in female patients with aggressive B-cell lymphoma. Ann Hematol. 2024 Nov;103(11):4599-4606. doi: 10.1007/s00277-024-05973-9. Epub 2024 Sep 4.
    pmid
    39227453
    type
    DERIVED
  3. citation
    Kuhnl A, Cunningham D, Counsell N, Hawkes EA, Qian W, Smith P, Chadwick N, Lawrie A, Mouncey P, Jack A, Pocock C, Ardeshna KM, Radford J, McMillan A, Davies J, Turner D, Kruger A, Johnson PW, Gambell J, Rosenwald A, Ott G, Horn H, Ziepert M, Pfreundschuh M, Linch D. Outcome of elderly patients with diffuse large B-cell lymphoma treated with R-CHOP: results from the UK NCRI R-CHOP14v21 trial with combined analysis of molecular characteristics with the DSHNHL RICOVER-60 trial. Ann Oncol. 2017 Jul 1;28(7):1540-1546. doi: 10.1093/annonc/mdx128.
    pmid
    28398499
    type
    DERIVED
  4. citation
    Pfreundschuh M, Poeschel V, Zeynalova S, Hanel M, Held G, Schmitz N, Viardot A, Dreyling MH, Hallek M, Mueller C, Wiesen MH, Witzens-Harig M, Truemper L, Keller U, Rixecker T, Zwick C, Murawski N. Optimization of rituximab for the treatment of diffuse large B-cell lymphoma (II): extended rituximab exposure time in the SMARTE-R-CHOP-14 trial of the german high-grade non-Hodgkin lymphoma study group. J Clin Oncol. 2014 Dec 20;32(36):4127-33. doi: 10.1200/JCO.2013.54.6861. Epub 2014 Nov 17.
    pmid
    25403207
    type
    DERIVED
  5. citation
    Bittenbring JT, Neumann F, Altmann B, Achenbach M, Reichrath J, Ziepert M, Geisel J, Regitz E, Held G, Pfreundschuh M. Vitamin D deficiency impairs rituximab-mediated cellular cytotoxicity and outcome of patients with diffuse large B-cell lymphoma treated with but not without rituximab. J Clin Oncol. 2014 Oct 10;32(29):3242-8. doi: 10.1200/JCO.2013.53.4537. Epub 2014 Aug 18.
    pmid
    25135997
    type
    DERIVED
  6. citation
    Held G, Murawski N, Ziepert M, Fleckenstein J, Poschel V, Zwick C, Bittenbring J, Hanel M, Wilhelm S, Schubert J, Schmitz N, Loffler M, Rube C, Pfreundschuh M. Role of radiotherapy to bulky disease in elderly patients with aggressive B-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1112-8. doi: 10.1200/JCO.2013.51.4505. Epub 2014 Feb 3.
    pmid
    24493716
    type
    DERIVED
  7. citation
    Horn H, Ziepert M, Becher C, Barth TF, Bernd HW, Feller AC, Klapper W, Hummel M, Stein H, Hansmann ML, Schmelter C, Moller P, Cogliatti S, Pfreundschuh M, Schmitz N, Trumper L, Siebert R, Loeffler M, Rosenwald A, Ott G; German High-Grade Non-Hodgkin Lymphoma Study Group. MYC status in concert with BCL2 and BCL6 expression predicts outcome in diffuse large B-cell lymphoma. Blood. 2013 Mar 21;121(12):2253-63. doi: 10.1182/blood-2012-06-435842. Epub 2013 Jan 18.
    pmid
    23335369
    type
    DERIVED
  8. citation
    Muller C, Murawski N, Wiesen MH, Held G, Poeschel V, Zeynalova S, Wenger M, Nickenig C, Peter N, Lengfelder E, Metzner B, Rixecker T, Zwick C, Pfreundschuh M, Reiser M. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012 Apr 5;119(14):3276-84. doi: 10.1182/blood-2011-09-380949. Epub 2012 Feb 15.
    pmid
    22337718
    type
    DERIVED
Source notices and limitations
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      source update dates
      1. context
        Updated: May 12, 2025
        datetime
        2025-05-12T12:00:00Z
        display
        May 12, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice