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NCT00278161 · REGISTRY CONDITION SEARCH

Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or 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
2018-11-05

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, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell 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

Engraftment

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outcome · POSTED

Non-relapse Mortality

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outcome · POSTED

Event-free 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
DISEASE CHARACTERISTICS: * One of the following B-cell leukemias or lymphomas, as defined by World Health Organization criteria: * Chronic lymphocytic leukemia/small lymphocytic lymphoma * B-cell prolymphocytic leukemia * Lymphoplasmacytic leukemia * Marginal zone lymphoma (splenic, extranodal, or nodal) * Follicular lymphoma (grade 1 or 2) * Mantle cell lymphoma * No more than minimal (approximately 10%) morphologically identifiable cancer cells on bone marrow biopsy * When cancer cells are morphologically difficult to distinguish from normal cells, flow cytometry must show no more than 10% identifiable cancer cells * Must have received ≤ 12 months of prior cytotoxic therapy, achieving at least a partial response NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 * Serum creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 2 mg/dL unless secondary to tumor * AST or ALT \< 2 times upper limit of normal * Normal (≥ 45%) left ventricular cardiac ejection fraction (determined by echocardiogram or MUGA scan) * DLCO \> 50% predicted * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known sensitivity to E. coli-derived products (e.g. filgrastim \[G-CSF\], insulin, asparaginase, growth hormone, or recombinant interferon alfa-2b) or any treatment study drugs * No active infections requiring oral or intravenous antibiotics * No other second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix unless the malignancy was localized and treated or resected with \> 90% probability of cure PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior anti-CD20 therapy allowed provided patient achieved a partial or complete response * No concurrent steroids during rituximab administration
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
    Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
    intervention Names
    1. Biological: Pegfilgrastim
    2. Biological: Rituximab
    3. Drug: Cyclophosphamide
    label
    R-HiCy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. R-HiCy
    description
    6 mg SQ 24-48 hours after last dose of cyclophosphamide.
    name
    Pegfilgrastim
    other Names
    1. Neulasta
    type
    BIOLOGICAL
  2. arm Group Labels
    1. R-HiCy
    description
    375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
    name
    Rituximab
    other Names
    1. Rituxan
    type
    BIOLOGICAL
  3. arm Group Labels
    1. R-HiCy
    description
    50 mg/kg/day on Days 15, 16, 17, and 18.
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    2. Cy
    3. CTX
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
94
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.
    measure
    Engraftment
    time Frame
    Up to 43 days
  2. description
    Number of participants who died for reasons related to protocol treatment.
    measure
    Non-relapse Mortality
    time Frame
    5 years
  3. description
    Percentage of participants alive without disease relapse.
    measure
    Event-free Survival
    time Frame
    5 years
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, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
detailed Description
OBJECTIVES: * Determine the safety of high-dose cyclophosphamide, rituximab, and pegfilgrastim in patients with B-cell leukemia or low-grade or mantle cell lymphoma. * Determine the molecular response rate in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive rituximab IV over 30-60 minutes on days 1, 4, 8,11, 45, and 52, cyclophosphamide IV over 1 hour on days 15-18, and pegfilgrastim subcutaneously on day 19 or 20 in the absence of unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Source references
references
  1. citation
    Gladstone DE, Bolanos-Meade J, Huff CA, Zahurak M, Flinn I, Borrello I, Luznik L, Fuchs E, Kasamon Y, Matsui W, Powell J, Levitsky H, Brodsky RA, Ambinder R, Jones RJ, Swinnen LJ. High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas. Leuk Lymphoma. 2011 Nov;52(11):2076-81. doi: 10.3109/10428194.2011.594191. Epub 2011 Jul 14.
    pmid
    21756035
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
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      offset unit
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      query cond
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      query disease state id
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      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
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      source json pointer
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      source kind
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice