Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

University College, London

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

Detailed Description

OBJECTIVES: * To determine whether rituximab, in combination with non-cardiotoxic chemotherapy comprising gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone, is effica...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2011

    Estimated Enrollment :

    62 Patients enrolled

    Trial Details

    Trial ID

    NCT00971763

    Start Date

    March 1 2006

    End Date

    July 1 2011

    Last Update

    December 4 2014

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, United Kingdom, BN2 5BE

    2

    Leeds General Infirmary

    Leeds, England, United Kingdom, LS1 3EX

    3

    Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, United Kingdom, LS9 7TF

    4

    Cancer Research UK and University College London Cancer Trials Centre

    London, England, United Kingdom, SE1 9RT