Skip to content
Triangle logo TriangleGet started
← Study library

NCT00088881 · REGISTRY CONDITION SEARCH

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-05-25

This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.

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.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.

→

outcome · POSTED

Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.

→

outcome · POSTED

3-year Time to Treatment Failure (TTF) Rate

→

outcome · POSTED

3-year Overall Survival (OS) Rate

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma * Patients must be stage I or II (Modified Ann Arbor staging) * Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging; patients must have at least one objective measurable disease parameter (a lesion with at least 1 dimension \> 1.5 cm); or if they are stage 1 * Stage I patients must have at least one of the following risk factors: * Age \>= 60 years * Bulky disease (\>= 5 cm in at least one dimension) * Elevated Lactate Dehydrogenase (LDH) above institutional upper limit of normal * Eastern Cooperative Oncology Group (ECOG) performance status = 2 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count \>= 1500/mm\^3 (includes neutrophils and bands) * Platelet count \>= 100,000/mm\^3 * Creatinine \< 2.0 mg/dl * Total bilirubin \< 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by lymphoma); patients with elevated total bilirubin should have a direct bilirubin checked; if the direct bilirubin is normal there is no need for a dose reduction * Patients must have left ventricular ejection fraction (LVEF) of \> 45% * Patients must be tested for hepatitis B (HBV) surface antigen within 2 weeks of registration * NOTE: Patients who test positive will be allowed to participate but must be followed closely for clinical and laboratory signs of active HBV infection and for signs of hepatitis Exclusion Criteria: * Prior chemotherapy, radiation therapy, radioimmunotherapy, or immunotherapy; a short course (=\< 14 days prior to registration) of corticosteroids is allowed * Evidence of other malignancy: * Prior chemotherapy or prior radiation therapy for other malignancies * Currently receiving hormone therapy or chemotherapy for another malignancy even if the treatment is being provided in the adjuvant treatment setting, i.e. with no evidence of the original other malignancy * Adjuvant hormonal therapy must have been discontinued \> 3 months before entering this study * Patients are eligible if they meet the following conditions: (a) treated carcinoma-in-situ of the cervix; (b) treated squamous cell or basal cell skin cancer; or (c) any other surgically cured malignancy from which the patient has been disease free for at least 3 years * Pregnant or breast feeding, as there would be radiation exposure to the fetus or child; a negative pregnancy test is required =\< 1 week prior to registration for women of childbearing potential (WOCBP). Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception * Known central nervous system (CNS) lymphoma, testicular lymphoma, or vitreous lymphoma * Known HIV infection. The safety of Zevalin™ in this population has not been tested at this time * Serious coexisting medical condition or active infection which would compromise the ability to deliver standard R-CHOP chemotherapy * Evidence of myelodysplasia on bone marrow aspiration and biopsy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone): Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients with progressive disease go off study. Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Radiation therapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
    intervention Names
    1. Biological: rituximab
    2. Drug: prednisone
    3. Drug: cyclophosphamide
    4. Drug: doxorubicin
    5. Drug: vincristine
    6. Radiation: indium In 111 ibritumomab tiuxetan
    7. Radiation: radiation therapy
    8. Procedure: positron emission tomography
    label
    Treatment
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Treatment
    description
    Given orally
    name
    prednisone
    other Names
    1. DeCortin
    2. Deltra
    type
    DRUG
  3. arm Group Labels
    1. Treatment
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    type
    DRUG
  4. arm Group Labels
    1. Treatment
    description
    Given IV
    name
    doxorubicin
    other Names
    1. ADM
    2. ADR
    3. Adria
    4. Adriamycin PFS
    5. Adriamycin RDF
    type
    DRUG
  5. arm Group Labels
    1. Treatment
    description
    Given IV
    name
    vincristine
    other Names
    1. leurocristine sulfate
    2. VCR
    3. Vincasar PFS
    type
    DRUG
  6. arm Group Labels
    1. Treatment
    description
    Given IV
    name
    indium In 111 ibritumomab tiuxetan
    other Names
    1. IDEC-In2B8
    type
    RADIATION
  7. arm Group Labels
    1. Treatment
    description
    Undergo radiotherapy
    name
    radiation therapy
    other Names
    1. irradiation
    2. radiotherapy
    3. therapy, radiation
    type
    RADIATION
  8. arm Group Labels
    1. Treatment
    description
    Undergo PET scans
    name
    positron emission tomography
    other Names
    1. FDG-PET
    2. PET
    3. PET scan
    4. tomography, emission computed
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
62
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently \> 1.5 cm in greatest diameter that has decreased by \> 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by \> 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
    measure
    Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
    time Frame
    Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
  2. description
    Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of \>50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by \>50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.
    measure
    Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
    time Frame
    Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
secondary Outcomes
  1. description
    Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.
    measure
    3-year Time to Treatment Failure (TTF) Rate
    time Frame
    Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.
  2. description
    Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.
    measure
    3-year Overall Survival (OS) Rate
    time Frame
    Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.
Full study description
brief Summary
This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the complete response rate (CR) and functional CR rate in patients with previously untreated stage I (with at least 1 risk factor) or stage II CD20+ diffuse large cell lymphoma who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin™. SECONDARY OBJECTIVES: I. To evaluate the time to treatment failure, duration of response, and overall survival in these patients who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin™. II. To evaluate the toxicity of this therapy. III. To evaluate the toxicity of adding involved field radiation therapy \> 12 weeks after Zevalin™ for patients with CT+/PET+ residual masses. TERTIARY OBJECTIVES: I. To evaluate PET scans pre -and post - R-CHOP/Zevalin™ therapy. OUTLINE: R-CHOP (rituximab, prednisone, cyclophosphamide, doxorubicin,vincristine): Patients receive oral prednisone once daily on days 1-5. Patients also receive rituximab IV over several hours followed by cyclophosphamide IV, doxorubicin IV, and vincristine IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study. Radioimmunotherapy: Beginning no more than 9 weeks after the reevaluation (or 12 weeks after the last dose of R-CHOP), patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium 90-Yttrium ibritumomab tiuxetan IV over 10 minutes on day 8. Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-4211b8070539dbba50cb
      requested nct id
      NCT00088881
      primary nct id
      NCT00088881
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      eb60c1b9dec93bf4a492d88430fc792b91a4f0438d458a53ea5bfc8847b8f8a9
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-4211b8070539dbba50cb
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00088881
      occurrences
      1. context exact
        NCT00088881
        end
        11
        exact text
        NCT00088881
        start
        0
      offset unit
      unicode_code_points
      query cond
      Testicular Cancer
      query disease state id
      ds-testicular-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      source json pointer
      /studies/45/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      95ee89851640bfe974c3c19e90aead4d88b51cd53b69a2eea18e9a50c2b87a5f
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-fc22098df465b6a6ff4f
      requested nct id
      NCT00088881
      primary nct id
      NCT00088881
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      7d640dc736ccaf26d3695b6ac2ddee882b1f7d7e7c99f489c27be2696df7a13c
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-fc22098df465b6a6ff4f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00088881
      occurrences
      1. context exact
        NCT00088881
        end
        11
        exact text
        NCT00088881
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/814/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      95ee89851640bfe974c3c19e90aead4d88b51cd53b69a2eea18e9a50c2b87a5f

    Preserved source evidence · Not medical advice