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NCT00278421 · CITED IN SOURCE DOCUMENTS

Rituximab and Combination Chemotherapy in Treating 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
2021-03-11

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

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 B-cell non-Hodgkin's lymphoma, including the following subtypes: * Grade 3 follicular lymphoma * Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants: * Centroblastic * Immunoblastic * Plasmablastic * Anaplastic large cell * T-cell-rich B-cell lymphoma * Primary effusion lymphoma * Intravascular B-cell lymphoma * Primary mediastinal B-cell lymphoma * Burkitt's or Burkitt-like lymphoma * Mantle cell lymphoma (blastoid) * Aggressive marginal zone lymphoma (monocytoid) * Previously untreated disease * CD20-positive disease * International Prognostic Index (IPI) score 0 * No bulky disease * Largest single or conglomerate tumor \< 7.5 cm in diameter * No mucosa-associated lymphoid tissue (MALT) lymphoma * No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 2,500/mm\^3 * Lactate dehydrogenase normal * Not pregnant or lactating * Fertile patients must use effective contraception during and for 1 year after study participation * Negative pregnancy test * No known hypersensitivity to the study medications * No known HIV-positivity * No active hepatitis infection * No impaired left ventricular function * No severe cardiac arrhythmias * No other impaired organ function * No other serious disorder * No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No prior immunosuppressive treatment with cytostatics * No planned radiotherapy to extranodal involvement * No concurrent participation in other treatment studies
healthy Volunteers
false
maximum Age
60 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP.
    intervention Names
    1. Biological: rituximab
    2. Drug: cyclophosphamide
    3. Drug: doxorubicin hydrochloride
    4. Drug: prednisone
    5. Drug: vincristine sulfate
    label
    Interventional: 6 R-CHOP-21
    type
    ACTIVE_COMPARATOR
  2. description
    Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone.
    intervention Names
    1. Biological: rituximab
    2. Drug: cyclophosphamide
    3. Drug: doxorubicin hydrochloride
    4. Drug: prednisone
    5. Drug: vincristine sulfate
    label
    Interventional: 4 R-CHOP-21 + 2 x R
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Interventional: 4 R-CHOP-21 + 2 x R
    2. Interventional: 6 R-CHOP-21
    name
    rituximab
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Interventional: 4 R-CHOP-21 + 2 x R
    2. Interventional: 6 R-CHOP-21
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. Interventional: 4 R-CHOP-21 + 2 x R
    2. Interventional: 6 R-CHOP-21
    name
    doxorubicin hydrochloride
    type
    DRUG
  4. arm Group Labels
    1. Interventional: 4 R-CHOP-21 + 2 x R
    2. Interventional: 6 R-CHOP-21
    name
    prednisone
    type
    DRUG
  5. arm Group Labels
    1. Interventional: 4 R-CHOP-21 + 2 x R
    2. Interventional: 6 R-CHOP-21
    name
    vincristine sulfate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
592
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Time to treatment failure (TTF) measured from day 1 of course 1 of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) therapy up to 3 years on study with life-long follow-up
    time Frame
    through study completion
secondary Outcomes
  1. measure
    Complete response (CR) rate duration until first relapse
    time Frame
    through study completion
  2. measure
    Progression rate during treatment
    time Frame
    through study completion
  3. measure
    Survival
    time Frame
    through study completion
  4. measure
    Tumor control measured from day 1 of course 1 of CHOP therapy (non-tumor related events are censored)
    time Frame
    through study completion
  5. measure
    Disease-free survival measured from day 1 of course 1 of CHOP therapy
    time Frame
    through study completion
  6. measure
    Safety (adverse events, serious adverse events) assessed at 3 months after treatment
    time Frame
    through study completion
Full study description
brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
detailed Description
OBJECTIVES: Primary * Compare the efficacy of 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with previously untreated, low-risk, aggressive B-cell non-Hodgkin's lymphoma. * Compare acute and chronic side effects in patients treated with these regimens. * Compare time to treatment failure in patients treated with these regimens. 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 participating center. Patients are randomized to 1 of 2 treatment arms. All patients are 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: Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 3 more courses of R-CHOP. * Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo restaging of their disease. Patients with disease progression proceed to salvage therapy off study. All other patients receive 1 more course of R-CHOP followed by 2 courses of rituximab alone. All patients undergo final restaging after 6 courses of rituximab. Patients with disease progression, stable disease, or partial response proceed to salvage therapy off study. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 622 patients will be accrued for this study.
Source references
references
  1. citation
    Poeschel V, Held G, Ziepert M, Witzens-Harig M, Holte H, Thurner L, Borchmann P, Viardot A, Soekler M, Keller U, Schmidt C, Truemper L, Mahlberg R, Marks R, Hoeffkes HG, Metzner B, Dierlamm J, Frickhofen N, Haenel M, Neubauer A, Kneba M, Merli F, Tucci A, de Nully Brown P, Federico M, Lengfelder E, di Rocco A, Trappe R, Rosenwald A, Berdel C, Maisenhoelder M, Shpilberg O, Amam J, Christofyllakis K, Hartmann F, Murawski N, Stilgenbauer S, Nickelsen M, Wulf G, Glass B, Schmitz N, Altmann B, Loeffler M, Pfreundschuh M; FLYER Trial Investigators; German Lymphoma Alliance. Four versus six cycles of CHOP chemotherapy in combination with six applications of rituximab in patients with aggressive B-cell lymphoma with favourable prognosis (FLYER): a randomised, phase 3, non-inferiority trial. Lancet. 2019 Dec 21;394(10216):2271-2281. doi: 10.1016/S0140-6736(19)33008-9.
    pmid
    31868632
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        d on single-arm retrospective trials.[<a href="#cit/section_7.8">8</a>]</p></li></ul></div></li><li>In a randomized prospective trial (<a href="/clinicaltrials/NCT00278421">NCT00278421</a>) of 592 patients younger than 60 years with nonbulky (&lt;7.5 cm) stage I or stage II DLBCL, patients were randomly assigned to receive either
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        rm retrospective trials.[<a href="#cit/section_7.8">8</a>]</p></li></ul></div></li><li>In a randomized prospective trial (<a href="/clinicaltrials/NCT00278421">NCT00278421</a>) of 592 patients younger than 60 years with nonbulky (&lt;7.5 cm) stage I or stage II DLBCL, patients were randomly assigned to receive either four or six
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      source title
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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