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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971763
• Other study ID #: CDR0000644293
• Secondary ID: UCL/05/1542005-0
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2009
• Last updated: December 3, 2014
• Start date: March 2006
• Est. completion date: July 2011

Study information

• Verified date: September 2009
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Biological:
• rituximab

Drug:
• cyclophosphamide

• gemcitabine hydrochloride

• prednisolone

• vincristine sulfate

Locations

Country	Name	City	State
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leeds General Infirmary	Leeds	England
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		End of treatment	No
Secondary	Toxicity		End of treatment	Yes
Secondary	Progression-free survival		Not specified in protocol	No
Secondary	Overall survival		Not specified in protocol	No