Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | 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 |
- Overall response rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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 |
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| United Kingdom | |
| Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting |
| Brighton, England, United Kingdom, BN2 5BE | |
| Contact: Contact Person 44-127-369-6955 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Contact Person 44-113-206-7995 | |
| Leeds General Infirmary | Recruiting |
| Leeds, England, United Kingdom, LS1 3EX | |
| Contact: Contact Person 44-113-206-7851 | |
| Cancer Research UK and University College London Cancer Trials Centre | Recruiting |
| London, England, United Kingdom, SE1 9RT | |
| Contact: Paul Fields, MD 44-207-188-0141 | |
| Principal Investigator: | Paul Fields, MD | Cancer Research UK |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00971763 History of Changes |
| Other Study ID Numbers: | CDR0000644293, UCL-CRUK-R-GCVP, EUDRACT-2005-003888-23, EU-20951 |
| Study First Received: | September 3, 2009 |
| Last Updated: | September 9, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 Cyclophosphamide Gemcitabine Rituximab Prednisolone Methylprednisolone Hemisuccinate |
Vincristine Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013