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

NCT ID: NCT00971763

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-07-31

Brief 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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

prednisolone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Interventions

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

prednisolone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Fields, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Research UK

Locations

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, United Kingdom

Leeds General Infirmary

Leeds, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Cancer Research UK and University College London Cancer Trials Centre

London, England, United Kingdom

Countries

United Kingdom

References

Fields PA, Townsend W, Webb A, Counsell N, Pocock C, Smith P, Jack A, El-Mehidi N, Johnson PW, Radford J, Linch DC, Cunnningham D. De novo treatment of diffuse large B-cell lymphoma with rituximab, cyclophosphamide, vincristine, gemcitabine, and prednisolone in patients with cardiac comorbidity: a United Kingdom National Cancer Research Institute trial. J Clin Oncol. 2014 Feb 1;32(4):282-7. doi: 10.1200/JCO.2013.49.7586. Epub 2013 Nov 12.

Reference Type: DERIVED

PMID: 24220559 (View on PubMed)

Other Identifiers

UCL/05/154

Identifier Type: OTHER

Identifier Source: secondary_id

2005-003888-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EU-20951

Identifier Type: -

Identifier Source: secondary_id

CDR0000644293

Identifier Type: -

Identifier Source: org_study_id