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:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00971763
First received: September 3, 2009
Last updated: December 3, 2014
Last verified: September 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Not specified in protocol ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Not specified in protocol ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971763

Locations
United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
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

Additional Information:
No publications provided by University College, London

Additional 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, 2005-003888-23, EU-20951
Study First Received: September 3, 2009
Last Updated: December 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Gemcitabine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Rituximab
Vincristine
Alkylating Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on April 30, 2015