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NCT00389818 · REGISTRY CONDITION SEARCH

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell 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
COMPLETED
Registry last update
2018-06-06

RATIONALE: 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. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related 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.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .

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outcome · NOT POSTED

Duration of Response

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outcome · NOT POSTED

Median Survival Time

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outcome · NOT POSTED

Rate of Bacterial, Fungal, and Opportunistic Infections

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outcome · NOT POSTED

Relationship Between MDR-1 Expression and Response to Treatment

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outcome · NOT POSTED

Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue

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outcome · NOT POSTED

Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time

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outcome · NOT POSTED

Mortality and Cause of Death

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outcome · NOT POSTED

Event-free Survival at 1 Year

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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
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed AIDS-related B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes: * Grade III follicular large cell lymphoma * Diffuse large B-cell lymphoma * Immunoblastic lymphoma * Plasmablastic lymphoma * Primary effusion lymphoma * Previously untreated disease * Any stage disease * CD20 positive disease * Must have documented HIV infection * Documentation may be by serology (enzyme-linked immunosorbent assay, western blot), culture, or quantitative polymerase chain reaction or branched DNA assays * Prior documentation of HIV seropositivity allowed * Measurable or nonmeasurable disease * Currently receiving effective highly active anti-retroviral therapy * No primary CNS lymphoma, including parenchymal brain or spinal cord lymphoma * No presence of leptomeningeal disease (positive cerebrospinal fluid for lymphoma) or presence of metastatic disease to brain, in terms of any mass lesion PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% * Life expectancy ≥ 2 months * Absolute granulocyte (neutrophil) count ≥ 1,000/mm³ (unless secondary to lymphomatous involvement of bone marrow) * Platelet count ≥ 75,000/mm³ (unless secondary to lymphomatous involvement of bone marrow or due to HIV-related thrombocytopenia) * Bilirubin ≤ 2.0 mg/dL (unless elevated secondary to lymphomatous involvement of liver or biliary system or due to other HIV medications \[e.g., indinavir, tenofavir, or atazanavir\]) * SGOT ≤ 5 times upper limit of normal * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min (unless secondary to renal involvement by lymphoma) * LVEF normal by MUGA or echocardiogram * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma that does not require systemic therapy * No serious, ongoing, nonmalignant disease or infection that would preclude study compliance, in the opinion of the investigator * No history of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for ≥ 2 days * No acute, intercurrent infection that would preclude study treatment * Patients with Mycobacterium avium are eligible * No cardiovascular problems, including any of the following: * Myocardial infarction within the past 6 months * New York Heart Association class II-IV heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Clinically significant pericardial disease * ECG evidence of acute ischemic or active conduction system abnormalities. * No shortness of breath at rest * Arterial PO\_2 ≥ 70 or pulse oximeter-derived O\_2 saturation ≥ 94% on room air (unless due to lymphomatous involvement of the lungs) * Able to comply with study and provide adequate informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior major surgery (except diagnostic surgery) * At least 12 months since prior rituximab unless it was only given for indications other than the treatment of aggressive lymphoma * No prior cytotoxic chemotherapy or radiotherapy for this lymphoma * Concurrent radiotherapy, with or without steroids, for emergency conditions secondary to lymphoma (i.e., CNS tumor or cord compression) allowed * No zidovudine or zidovudine-containing regimen (including Combivir® or Trizivir®) during and for 2 months after completion of chemotherapy * Concurrent erythropoietin or filgrastim (G-CSF) allowed * Growth factor therapy must be discontinued ≥ 24 hours prior to study entry
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Single arm interventional study: all subjects receive DR-COP regimen.
    intervention Names
    1. Biological: filgrastim
    2. Biological: pegfilgrastim
    3. Biological: rituximab
    4. Biological: sargramostim
    5. Drug: cyclophosphamide
    6. Drug: pegylated liposomal doxorubicin hydrochloride
    7. Drug: prednisone
    8. Drug: vincristine sulfate
    9. Other: immunohistochemistry staining method
    10. Other: laboratory biomarker analysis
    label
    DR-COP
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. DR-COP
    description
    Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
    name
    filgrastim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. DR-COP
    description
    GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
    name
    pegfilgrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. DR-COP
    description
    375 mg/m2 IV Day 1 of each cycle
    name
    rituximab
    type
    BIOLOGICAL
  4. arm Group Labels
    1. DR-COP
    description
    GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
    name
    sargramostim
    type
    BIOLOGICAL
  5. arm Group Labels
    1. DR-COP
    description
    750 mg/m2 IV Day 1 of each cycle
    name
    cyclophosphamide
    type
    DRUG
  6. arm Group Labels
    1. DR-COP
    description
    40 mg/m2 IV Day 1 of each cycle
    name
    pegylated liposomal doxorubicin hydrochloride
    type
    DRUG
  7. arm Group Labels
    1. DR-COP
    description
    100 mg PO Days 1-5 of each cycle
    name
    prednisone
    type
    DRUG
  8. arm Group Labels
    1. DR-COP
    description
    1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle
    name
    vincristine sulfate
    type
    DRUG
  9. arm Group Labels
    1. DR-COP
    description
    tissue specimen collected at baseline
    name
    immunohistochemistry staining method
    type
    OTHER
  10. arm Group Labels
    1. DR-COP
    description
    tissue specimen collected at baseline
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
43
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
    time Frame
    After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
  2. measure
    Duration of Response
    time Frame
    After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
  3. measure
    Median Survival Time
    time Frame
    After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
  4. measure
    Rate of Bacterial, Fungal, and Opportunistic Infections
    time Frame
    After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
secondary Outcomes
  1. measure
    Relationship Between MDR-1 Expression and Response to Treatment
    time Frame
    Baseline
  2. measure
    Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue
    time Frame
    Baseline, after cycles 4 and 6, 1 month after treatment discontinuation
  3. measure
    Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time
    time Frame
    After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
  4. measure
    Mortality and Cause of Death
    time Frame
    At any time through the third year after treatment discontinuation
  5. measure
    Event-free Survival at 1 Year
    time Frame
    1 year post-treatment
Full study description
brief Summary
RATIONALE: 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. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.
detailed Description
OBJECTIVES: Primary * Determine the complete response rate (complete response and complete response unconfirmed) in patients with newly diagnosed, AIDS-related B-cell non-Hodgkin's lymphoma treated with doxorubicin hydrochloride liposome, rituximab, cyclophosphamide, vincristine, and prednisone (DR-COP). * Determine the duration of response (relapse-free survival) in patients treated with this regimen. * Determine the median survival time of patients treated with this regimen. * Determine rate of bacterial, fungal, and opportunistic infections in patients treated with this regimen. Secondary * Determine, preliminarily, the relationship between MDR-1 expression in tumor tissue and response to therapy in patients treated with this regimen. * Determine, preliminarily, any relationship between response and survival and BCL-2 expression in tumor tissue in patients treated with this regimen. * Determine any relationship between development of bacterial, fungal, and/or opportunistic infections and baseline CD4 lymphocyte count, HIV-1 RNA level, and quantitative immunoglobulin levels, or changes in quantitative immunoglobulin levels over time in patients treated with this regimen. * Compare the results of positron emission tomography (PET) scanning with traditional CT scans in predicting response to therapy in these patients. * Examine the relationship between chemotherapeutic drug levels and receipt of specific antiretroviral and/or anti-infective medications in these patients. * Examine the mortality and the causes of death in patients treated with this regimen. * Determine event-free survival at 1 year. OUTLINE: This is a nonrandomized, multicenter study. Patients receive doxorubicin hydrochloride liposome IV over 90 minutes, rituximab IV over 5-7 hours, cyclophosphamide IV over 1 hour, and vincristine IV over 1-2 minutes on day 1 and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21-28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory/biomarker studies at baseline and after every 2 courses of chemotherapy. Tissue is examined by immunohistochemistry for BCL-2, Ki67, and MDR-1, along with other markers. After completion of study treatment, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Source references
references
  1. citation
    Levine AM, Noy A, Lee JY, Tam W, Ramos JC, Henry DH, Parekh S, Reid EG, Mitsuyasu R, Cooley T, Dezube BJ, Ratner L, Cesarman E, Tulpule A. Pegylated liposomal doxorubicin, rituximab, cyclophosphamide, vincristine, and prednisone in AIDS-related lymphoma: AIDS Malignancy Consortium Study 047. J Clin Oncol. 2013 Jan 1;31(1):58-64. doi: 10.1200/JCO.2012.42.4648. Epub 2012 Nov 19.
    pmid
    23169503
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice