Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278161
Recruitment Status : Completed
First Posted : January 18, 2006
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Pegfilgrastim Biological: Rituximab Drug: Cyclophosphamide Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma
Study Start Date : January 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: R-HiCy
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Biological: Pegfilgrastim
6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Other Name: Neulasta

Biological: Rituximab
375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.
Other Name: Rituxan

Drug: Cyclophosphamide
50 mg/kg/day on Days 15, 16, 17, and 18.
Other Names:
  • Cytoxan
  • Cy
  • CTX

Primary Outcome Measures :
  1. Engraftment [ Time Frame: Up to 43 days ]
    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.

  2. Non-relapse Mortality [ Time Frame: 5 years ]
    Number of participants who died for reasons related to protocol treatment.

  3. Event-free Survival [ Time Frame: 5 years ]
    Percentage of participants alive without disease relapse.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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


  • See Disease Characteristics
  • Prior anti-CD20 therapy allowed provided patient achieved a partial or complete response
  • No concurrent steroids during rituximab administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278161

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Study Chair: Lode J. Swinnen, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications of Results:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00278161     History of Changes
Other Study ID Numbers: J0260
P50CA096888 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00041511 ( Other Identifier: JHMIRB )
First Posted: January 18, 2006    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
small lymphocytic lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
B-cell chronic lymphocytic leukemia
splenic marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
Waldenstrom macroglobulinemia
prolymphocytic leukemia
stage I marginal zone lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists