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

Sponsor
University College, London
Study ID
NCT00971763
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • gemcitabine hydrochloride — DRUG
  • prednisolone — DRUG
  • vincristine sulfate — DRUG

Study Details

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.

Key Dates

Start date
Mar 31, 2006
Status verified
Sep 2009
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall response rate [ Time Frame: End of treatment ]

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