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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
gemcitabine hydrochloride
prednisolone
vincristine sulfate
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sussex Cancer Centre at Royal Sussex County Hospital
  • Leeds General Infirmary
  • Leeds Cancer Centre at St. James's University Hospital
  • Cancer Research UK and University College London Cancer Trials Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-GCVP

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Toxicity
Progression-free survival
Overall survival

Full Information

First Posted
September 3, 2009
Last Updated
December 3, 2014
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT00971763
Brief Title
Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-GCVP
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
End of treatment
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
End of treatment
Title
Progression-free survival
Time Frame
Not specified in protocol
Title
Overall survival
Time Frame
Not specified in protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Fields, MD
Organizational Affiliation
Cancer Research UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
State/Province
England
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Cancer Research UK and University College London Cancer Trials Centre
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24220559
Citation
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. Erratum In: J Clin Oncol. 2014 Oct 20;32(30):3461.
Results Reference
derived

Learn more about this trial

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

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