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NCT00274924 · CITED IN SOURCE DOCUMENTS

Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell 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
PHASE2
Status at capture
COMPLETED
Registry last update
2023-06-29

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy 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. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.

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What did the study report?

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

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

2-year Progression-Free Survival (PFS)

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outcome · POSTED

5-year Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
INCLUSION CRITERIA: * Diffuse large B-cell non-Hodgkin's lymphoma * Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease * The following lymphoma types are excluded: * Primary central nervous system lymphoma * Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear presence of low-grade lymphoma on histologic sections) * Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative radiotherapy is usually indicated) * Immunodeficiency-related lymphoma (i.e., after organ or bone marrow transplant) * Measurable disease * Patient must have at least one objective measurable disease site (i.e., measurable in at least 2 perpendicular parameters) * Measurable disease in the liver is required if the liver is the only site of lymphoma involvement * Abnormal positron emission tomography scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * For patients \> 50 years of age, a normal ejection fraction by ECHO or Multigated Acquisition Scan (MUGA) is required within 6 weeks prior to registration * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine \< 2.0 mg/dL * Bilirubin \< 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma) EXCLUSION CRITERIA: * Prior chemotherapy or radiation therapy for lymphoma * Prior anthracyclines or platinum compounds used as systemic chemotherapy * Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow * Concurrent pentostatin or trastuzumab (Herceptin®) * Pregnant or nursing * Prior malignancy within the past 5 years unless it was in situ OR was treated with curative intent AND the patient has remained relapse-free * HIV positive
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Biological: rituximab
    2. Drug: cyclophosphamide
    3. Drug: doxorubicin hydrochloride
    4. Drug: prednisone
    5. Drug: vincristine
    label
    Group I (PET negative)
    type
    EXPERIMENTAL
  2. description
    Patients receive R-ICE comprising rituximab IV on day 1, ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day 2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously once daily starting on day 4 and continuing until blood counts recover. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Biological: filgrastim
    2. Biological: rituximab
    3. Drug: carboplatin
    4. Drug: cyclophosphamide
    5. Drug: etoposide
    6. Drug: ifosfamide
    label
    Group II (PET positive)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Group II (PET positive)
    description
    Given subcutaneously or intravenous bolus.
    name
    filgrastim
    other Names
    1. G-CSF, Neupogen, recombinant-methionyl human granulocyte-colony stimulating
    2. factor, granulocyte colony-stimulating factor, r-metHuG-CSF.
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Group I (PET negative)
    2. Group II (PET positive)
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody, Rituxan.
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Group II (PET positive)
    description
    Given IV
    name
    carboplatin
    other Names
    1. CBDCA, Paraplatin, JM-8, NSC #241240.
    type
    DRUG
  4. arm Group Labels
    1. Group I (PET negative)
    2. Group II (PET positive)
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. Cytoxan, Neosar, CTX, CPM.
    type
    DRUG
  5. arm Group Labels
    1. Group I (PET negative)
    description
    Given IV
    name
    doxorubicin hydrochloride
    other Names
    1. Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin,
    2. hydroxydaunomycin, ADR.
    type
    DRUG
  6. arm Group Labels
    1. Group II (PET positive)
    description
    Given IV
    name
    etoposide
    other Names
    1. VP-16, VePesid, epipodophyllotoxin
    type
    DRUG
  7. arm Group Labels
    1. Group II (PET positive)
    description
    Given IV
    name
    ifosfamide
    other Names
    1. Isophosphamide, Ifex , Mitoxan , Holoxan , Naxamide ' NSC # 109724.
    type
    DRUG
  8. arm Group Labels
    1. Group I (PET negative)
    description
    Taken orally
    name
    prednisone
    other Names
    1. Deltasone, Orasone, Medicorten, Panasol-S, Liquid-Pred, others.
    type
    DRUG
  9. arm Group Labels
    1. Group I (PET negative)
    description
    Given IV
    name
    vincristine
    other Names
    1. Oncovin, Vincasar PFS vincristine sulfate, VCR, leucocristine, LCR.
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
100
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.
    measure
    2-year Progression-Free Survival (PFS)
    time Frame
    Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
secondary Outcomes
  1. description
    5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.
    measure
    5-year Overall Survival
    time Frame
    Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
Full study description
brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy 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. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.
detailed Description
OBJECTIVES: Primary * Determine the 2-year progression-free survival (PFS) rate after treatment with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide, vincristine, doxorubicin hydrochloride, and prednisone. Secondary * Determine the proportion of mid-treatment PET-positive patients who become PET-negative after 4 courses of R-ICE. * Determine the PFS of mid-treatment PET-negative patients treated with these regimens. * Determine the overall survival of patients treated with these regimens. * Determine the toxicity of these regimens in these patients. OUTLINE: * Rituximab and Combination Chemotherapy (R-CHOP: R= Rituximab, C= Cyclophosphamide, H= Doxorubicin Hydrochloride (Hydroxydaunomycin), O= Vincristine Sulfate (Oncovin), P= Prednisone): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F18 positron emission tomography (PET) scanning and conventional restaging during course 3. Based on the PET results, patients are assigned to 1 of 2 treatment groups. * Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the absence of disease progression or unacceptable toxicity. * Group II (PET positive): Patients receive Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 10 years from the date of study entry. ACCRUAL: A total of 100 patients were accrued for this study.
Source references
references
  1. citation
    Horning SJ, Juweid ME, Schoder H, Wiseman G, McMillan A, Swinnen LJ, Advani R, Gascoyne R, Quon A. Interim positron emission tomography scans in diffuse large B-cell lymphoma: an independent expert nuclear medicine evaluation of the Eastern Cooperative Oncology Group E3404 study. Blood. 2010 Jan 28;115(4):775-7; quiz 918. doi: 10.1182/blood-2009-08-234351. Epub 2009 Sep 18.
    pmid
    19767508
    type
    RESULT
Source notices and limitations
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    Preserved source evidence · Not medical advice