NCT00971763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 4, 2014

Status Verified

September 1, 2009

Enrollment Period

5.3 years

First QC Date

September 3, 2009

Last Update Submit

December 3, 2014

Conditions

Lymphoma

Keywords

stage I adult diffuse large cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    End of treatment

Secondary Outcomes (3)

  • Toxicity

    End of treatment

  • Progression-free survival

    Not specified in protocol

  • Overall survival

    Not specified in protocol

Study Arms (1)

R-GCVP

EXPERIMENTAL

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

Biological: rituximabDrug: cyclophosphamideDrug: gemcitabine hydrochlorideDrug: prednisoloneDrug: vincristine sulfate

Interventions

rituximabBIOLOGICAL
R-GCVP
cyclophosphamideDRUG
R-GCVP
gemcitabine hydrochlorideDRUG
R-GCVP
prednisoloneDRUG
R-GCVP
vincristine sulfateDRUG
R-GCVP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Cancer Research UK and University College London Cancer Trials Centre

London, England, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24220559DERIVED

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Interventions

RituximabCyclophosphamideGemcitabinePrednisoloneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Paul Fields, MD

    Cancer Research UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

March 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 4, 2014

Record last verified: 2009-09

Locations

GB(4)