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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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 ╬╝mol/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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Paul Fields, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Research UK

Authority:

Unspecified

Study ID:

CDR0000644293

NCT ID:

NCT00971763

Start Date:

March 2006

Completion Date:

Related Keywords:

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

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