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NCT00392834 · REGISTRY CONDITION SEARCH

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt'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: 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 newly diagnosed, HIV-associated Burkitt'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

Overall Survival (OS) at 1 Year

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outcome · NOT POSTED

Complete Response Rate

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outcome · NOT POSTED

Failure-free Survival (FFS)

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outcome · NOT POSTED

Event-free Survival (EFS)

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outcome · NOT POSTED

Toxicity

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outcome · NOT POSTED

Incidence of Infection-related Deaths

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outcome · NOT POSTED

Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS

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outcome · NOT POSTED

Utility of Flow Cytometry in Detecting Leptomeningeal Disease

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outcome · NOT POSTED

Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results

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outcome · NOT POSTED

Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS

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outcome · NOT POSTED

Correlation of EBV Load Measurements With OS, FFS, and EFS

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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 confirmed Burkitt's lymphoma (BL) or new WHO 2009 criteria B-cell lymphoma unclassified (with features intermediated between difuse large B-cell lymphoma and BL) * Any stage disease * Newly diagnosed disease * Meets 1 of the following criteria for disease risk: * Low-risk disease, defined by 1 of the following: * Stage I with a single focus of disease \< 10 cm AND normal lactate dehydrogenase (LDH) level * Totally resected intra-abdominal disease only AND normal LDH post surgery * High-risk disease, defined as not meeting criteria for low-risk disease * Measurable or nonmeasurable disease * HIV-positive confirmed by enzyme-linked immunosorbent assay and Western blot OR by measurable HIV viral load * No visceral Kaposi's sarcoma PATIENT CHARACTERISTICS: * Karnofsky performance status 40-100% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * LVEF ≥ 50% by MUGA or echocardiogram * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ (unless related to lymphoma)\* * Direct bilirubin ≤ 2.0 mg/dL OR total bilirubin ≤ 3.5 mg/dL AND direct bilirubin normal (if elevated bilirubin secondary to antiretroviral therapy) * AST and ALT ≤ 3 times upper limit of normal * No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or cutaneous Kaposi's sarcoma * No other medical illness unrelated to non-Hodgkin's lymphoma, including any of the following: * Uncontrolled infection (including opportunistic infection) * Chronic renal insufficiency * Myocardial infarction within the past 6 months * Unstable angina * Cardiac arrhythmias other than chronic atrial fibrillation * Patients with active hepatitis B infection are eligible provided they receive concurrent dual antiviral therapy NOTE: \*Patients with bone marrow involvement are eligible irrespective of blood count PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior therapy for this disease except for 1 of the following : * Seven consecutive days of steroids alone or in combination with a non-CHOP regimen necessary for patient stabilization (e.g., cyclophosphamide and steroids steroids for normalization of disease-related hyperbilirubinemia) * One course of CHOP or fractionated CHOP (e.g. CODOX) with or without rituximab * No epoetin alfa or filgrastim (G-CSF) within 24 hours of study chemotherapy * No concurrent zidovudine
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
    Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
    intervention Names
    1. Biological: filgrastim
    2. Biological: pegfilgrastim
    3. Biological: rituximab
    4. Drug: cyclophosphamide
    5. Drug: cytarabine
    6. Drug: doxorubicin hydrochloride
    7. Drug: leucovorin calcium
    8. Drug: liposomal cytarabine
    9. Drug: methotrexate
    10. Drug: therapeutic hydrocortisone
    11. Drug: vincristine sulfate
    label
    Regimen A (R-CODOX-M chemotherapy)
    type
    EXPERIMENTAL
  2. description
    Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
    intervention Names
    1. Biological: filgrastim
    2. Biological: pegfilgrastim
    3. Biological: rituximab
    4. Drug: cytarabine
    5. Drug: etoposide
    6. Drug: ifosfamide
    7. Drug: liposomal cytarabine
    8. Drug: methotrexate
    9. Drug: therapeutic hydrocortisone
    label
    Regimen B (rituximab and IVAC chemotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given subcutaneously
    name
    filgrastim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given subcutaneously
    name
    pegfilgrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given IV
    name
    rituximab
    type
    BIOLOGICAL
  4. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    description
    given IV
    name
    cyclophosphamide
    type
    DRUG
  5. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given intrathecally
    name
    cytarabine
    type
    DRUG
  6. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    description
    given IV
    name
    doxorubicin hydrochloride
    type
    DRUG
  7. arm Group Labels
    1. Regimen B (rituximab and IVAC chemotherapy)
    description
    given IV
    name
    etoposide
    type
    DRUG
  8. arm Group Labels
    1. Regimen B (rituximab and IVAC chemotherapy)
    description
    given IV
    name
    ifosfamide
    type
    DRUG
  9. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    description
    given IV
    name
    leucovorin calcium
    type
    DRUG
  10. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given intrathecally
    name
    liposomal cytarabine
    type
    DRUG
  11. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given intrathecally
    name
    methotrexate
    type
    DRUG
  12. arm Group Labels
    1. Regimen A (R-CODOX-M chemotherapy)
    2. Regimen B (rituximab and IVAC chemotherapy)
    description
    given intrathecally
    name
    therapeutic hydrocortisone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
34
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall Survival (OS) at 1 Year
    time Frame
    1 year post treatment
secondary Outcomes
  1. measure
    Complete Response Rate
    time Frame
    6-8 weeks post treatment, every 4 months post-treatment for 2 years
  2. measure
    Failure-free Survival (FFS)
    time Frame
    6-8 weeks post treatment, every 4 months post-treatment for 2 years
  3. measure
    Event-free Survival (EFS)
    time Frame
    6-8 weeks post treatment, every 4 months post-treatment for 2 years
  4. measure
    Toxicity
    time Frame
    baseline through 2 years post-treatment
  5. measure
    Incidence of Infection-related Deaths
    time Frame
    baseline through 2 years post-treatment
  6. measure
    Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS
    time Frame
    baseline through 2 years post-treatment
  7. measure
    Utility of Flow Cytometry in Detecting Leptomeningeal Disease
    time Frame
    baseline and 6-8 weeks post-treatment
  8. measure
    Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results
    time Frame
    baseline
  9. measure
    Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS
    time Frame
    baseline through 2 years post-treatment
  10. measure
    Correlation of EBV Load Measurements With OS, FFS, and EFS
    time Frame
    baseline through 2 years post-treatment
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 newly diagnosed, HIV-associated Burkitt's lymphoma.
detailed Description
OBJECTIVES: Primary * Determine the efficacy of rituximab, cyclophosphamide, vincristine, doxorubicin hydrochloride, and high-dose methotrexate (R-CODOX-M ) alone or alternating with rituximab and ifosfamide, etoposide phosphate, and high-dose cytarabine (IVAC) and intrathecal CNS prophylaxis in patients with newly diagnosed, previously untreated, HIV-associated Burkitt's lymphoma or atypical Burkitt's lymphoma. * Determine the safety of this regimen in these patients. Secondary * Evaluate downstream effectors of apoptosis as mechanisms of chemotherapy resistance and prognosis and perform exploratory analysis of their relationship to treatment effect. * Evaluate multi-drug resistance gene expression as a mechanism of chemotherapy resistance and prognosis and perform exploratory analysis of their relationship to treatment effect. * Confirm the use of flow cytometry in the identification of occult leptomeningeal disease and determine whether abnormal flow cytometry is predictive when CNS cytology is negative for malignant cells. * Determine the biologic and prognostic significance of Epstein-Barr virus (EBV)-positive Burkitt's lymphoma in the highly active antiretroviral therapy era and perform exploratory analysis of their relationship to treatment effect. * Compare genotyping in patients with HIV-associated Burkitt's lymphoma with that of patients who are HIV-negative and determine whether they are uniform in their genetic profile or whether some cases are more like diffuse large B-cell lymphoma. * Determine if EBV detection in cerebrospinal fluid at diagnosis is predictive of leptomeningeal disease. OUTLINE: This is a prospective, multicenter study. Patients are stratified according to risk category (low-risk vs high-risk). Patients with low-risk disease receive 3 courses of R-CODOX-M chemotherapy as described below. Patients with high-risk disease receive 4 alternating courses of R-CODOX-M/IVAC chemotherapy as described below in an A/B/A/B sequence.\* Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. NOTE: \*In patients presenting with anasarca, pleural effusion, or ascites, methotrexate can pool causing difficulties with clearance; in this case, treatment may be given in a reverse sequence: B/A/B/A. * Regimen A (R-CODOX-M chemotherapy): Patients receive rituximab\*\* IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim subcutaneously (SC) on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until the methotrexate level is less than 50 nmol/L. Patients receive CNS prophylaxis comprising methotrexate intrathecally (IT), cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive filgrastim (G-CSF) SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover. * Regimen B (rituximab and IVAC chemotherapy): Patients receive rituximab\*\* IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy. NOTE: \*\*Rituximab may be given up to 3 days before a chemotherapy course and anytime during the course for 3 (low-risk disease) or 4 (high-risk disease) total doses. Patients undergo blood and cerebrospinal fluid collection and tumor biopsies periodically during study treatment for correlative studies of prognostic biomarkers predictive of survival (e.g., c-flip protein expression; p53 mutations \[by immunohistochemistry (IHC)\]; multidrug resistance gene expression \[by IHC\]; and Epstein-Barr virus in tumor DNA or cerebrospinal fluid \[by polymerase chain reaction\]); genotyping of Burkitt's lymphoma; and flow cytometry as a tool (by staining) for detecting occult positivity of leptomeningeal disease in Burkitt's lymphoma. After completion of study treatment, patients are followed every 4 months for at least 2 years. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Source references
references
  1. citation
    Noy A, Lee JY, Cesarman E, Ambinder R, Baiocchi R, Reid E, Ratner L, Wagner-Johnston N, Kaplan L; AIDS Malignancy Consortium. AMC 048: modified CODOX-M/IVAC-rituximab is safe and effective for HIV-associated Burkitt lymphoma. Blood. 2015 Jul 9;126(2):160-6. doi: 10.1182/blood-2015-01-623900. Epub 2015 May 8.
    pmid
    25957391
    type
    RESULT
Source notices and limitations
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    Preserved source evidence · Not medical advice