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Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971763
First Posted: September 4, 2009
Last Update Posted: December 4, 2014
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.
Information provided by (Responsible Party):
University College, London
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone, 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 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. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying giving gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone together with rituximab to see how well it works in treating patients with newly diagnosed diffuse large B-cell lymphoma.


Condition Intervention Phase
Lymphoma Biological: rituximab Drug: cyclophosphamide Drug: gemcitabine hydrochloride Drug: prednisolone Drug: vincristine sulfate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicentre Trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the Treatment of Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma, Considered Unsuitable for R-CHOP Chemotherapy

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: End of treatment ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: End of treatment ]
  • Progression-free survival [ Time Frame: Not specified in protocol ]
  • Overall survival [ Time Frame: Not specified in protocol ]

Enrollment: 62
Study Start Date: March 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-GCVP

Up to 6 x 21 day cycles of R-GCVP:

  • Gemcitabine 750mg/m^2 days 1 & 8 (increasing to 875mg/m^2 for cycle 2 & 1g/m^2 for subsequent cycles if tolerated satisfactorily)
  • Cyclophosphamide 750mg/m^2 day 1
  • Vincristine 1.4mg/m^2 day 1 (capped at 2mg)
  • Prednisolone 100mg/day days 1-5
  • Rituximab 375mg/m^2 day 1
  • Neulasta 6mg day 9
Biological: rituximab Drug: cyclophosphamide Drug: gemcitabine hydrochloride Drug: prednisolone Drug: vincristine sulfate

Detailed Description:

OBJECTIVES:

  • To determine whether rituximab, in combination with non-cardiotoxic chemotherapy comprising gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone, is efficacious in a group of patients who are unfit for CHOP chemotherapy.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8; cyclophosphamide IV, vincristine sulfate IV, and rituximab IV on day 1; and oral prednisolone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed CD20-positive diffuse large B-cell non-Hodgkin lymphoma (DLBCL) according to the current WHO classification, including all morphological variants

    • Newly diagnosed disease
    • Bulky stage IA-IV disease

      • No non-bulky stage IA disease
  • Measurable disease
  • Not eligible for CHOP chemotherapy due to impaired cardiac function

    • Cardiac status that does not allow the administration of 8 courses of R-CHOP chemotherapy, as defined by 1 of the following criteria:

      • Ejection fraction less than 50% as assessed by either ECHO or MUGA scan
      • NYHA class III-IV
  • No high-grade transformation of low-grade lymphoma
  • No symptomatic central nervous system or meningeal involvement by the lymphoma
  • No AIDS-related lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Life expectancy > 3 months
  • Platelet count > 100 x 10^9/L
  • WBC > 3 x 10^9/L
  • Neutrophils > 1.5 x 10^9/L (unless elevated level attributed to bone marrow infiltration by lymphoma)
  • Serum bilirubin < 50 μmol/L
  • Transaminases < 2.5 times upper limit of normal (unless elevated level attributed to lymphoma)
  • Glomerular filtration rate > 30 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other concurrent uncontrolled medical condition
  • No active malignant disease, other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix, within the past 10 years
  • No positive serology for HIV
  • No medical or psychiatric conditions that compromise the patient's ability to give informed consent

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy, radiotherapy, or other investigational drug for this indication
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00971763


Locations
United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom, SE1 9RT
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Paul Fields, MD Cancer Research UK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00971763     History of Changes
Other Study ID Numbers: CDR0000644293
UCL/05/154 ( Other Identifier: University College London )
2005-003888-23 ( EudraCT Number )
EU-20951
First Submitted: September 3, 2009
First Posted: September 4, 2009
Last Update Posted: December 4, 2014
Last Verified: September 2009

Keywords provided by University College, London:
stage I adult diffuse large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Cyclophosphamide
Rituximab
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors