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Rituximab, Cyclophosphamide, and G-CSF Followed By Combination Chemotherapy in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant Followed By Rituximab and GM-CSF for Refractory Diffuse Large B-Cell 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: NCT00242996
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : September 28, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide, before transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. More rituximab is given after transplant to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory diffuse large B-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: rituximab Biological: sargramostim Drug: carmustine Drug: cyclophosphamide Drug: etoposide Procedure: adjuvant therapy Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the disease-free and overall survival of patients with refractory diffuse large B-cell lymphoma treated with stem cell mobilization comprising rituximab, cyclophosphamide, and filgrastim (G-CSF) followed by high-dose chemotherapy comprising carmustine, etoposide, and cyclophosphamide and autologous peripheral blood stem cell transplantation, rituximab, and sargramostim (GM-CSF).
  • Determine any potential infectious complications in patients treated with this regimen.
  • Determine the effect of GM-CSF on antibody-dependent cellular cytotoxicity in patients treated with this regimen.

OUTLINE: Stem cell mobilization: Patients receive rituximab IV over 4-8 hours on days 1, 5, 8, and 13. Patients also receive cyclophosphamide IV over 1-2 hours on day 9 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 10 and continuing until an adequate number of peripheral blood stem cells (PBSC) are collected.

High-dose preparative regimen: Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.

Autologous PBSC transplantation: Patients undergo autologous PBSC transplantation on day 0. Patients receive sargramostim (GM-CSF) SC once daily beginning on day 6 and continuing until blood counts recover.

Post-transplant regimen: Patients receive GM-CSF SC once daily on days 42-73, 177-208, 362-393, 543-574, and 727-758. Patients also receive rituximab IV over 4-8 hours on days 45, 52, 59, 66, 180,187, 194, 201, 365, 372, 379, 386, 546, 553, 560, 567, 730, 737, 744, and 751.

After completion of study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma
Study Start Date : March 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Primary Outcome Measures :
  1. 2-year event free survival

Secondary Outcome Measures :
  1. Overall survival

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


  • Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following criteria:

    • Failed to achieve at least partial remission
    • Failed to respond to prior primary therapy or salvage chemotherapy
    • Disease progression within 6 weeks after achieving remission
  • CD20 expression at diagnosis or relapse
  • No more than 4 prior regimens using chemotherapy, radiotherapy, or immunotherapy

    • The addition of radiotherapy or a monoclonal antibody to chemotherapy is considered 1 treatment regimen provided the addition was part of the initial treatment plan

      • The addition of these therapies due to lack of response or poor response is considered an additional treatment regimen whether given in the front line or salvage setting


Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Direct bilirubin ≤ 2 mg/dL
  • AST or ALT < 3 times upper limit of normal


  • Creatinine ≤ 2.0 mg/dL


  • Ejection fraction ≥ 40%


  • DLCO ≥ 60% of predicted


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No active infection requiring oral or IV antibiotics
  • HIV negative


Biologic therapy

  • See Disease Characteristics
  • See Radiotherapy


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior radioimmunotherapy

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): NCT00242996

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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)
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Study Chair: Lode J. Swinnen, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00242996     History of Changes
Other Study ID Numbers: J0376 CDR0000447158
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent adult diffuse large cell lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors