LymphomaPhase 2NCT00971763
Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
A Phase 2 study testing rituximab, cyclophosphamide and gemcitabine hydrochloride in people with Lymphoma, run by University College, London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, cyclophosphamide and gemcitabine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Mar 2006to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Leeds General Infirmary
Leeds, England, LS1 3EX
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Cancer Research UK and University College London Cancer Trials Centre
London, England, SE1 9RT
About this study
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
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- rituximab, cyclophosphamide, gemcitabine hydrochloride, prednisolone, vincristine sulfate
- 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
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
cyclophosphamideDrug
prednisoloneDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: gemcitabine hydrochloride; Drug: prednisolone; Drug: vincristine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: End of treatment
Secondary outcomes (3)
Toxicity
Measured: End of treatment
Progression-free survival
Measured: Not specified in protocol
Overall survival
Measured: Not specified in protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMar 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Fields, MD, Principal investigator, Cancer Research UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971763
- Sponsor's protocol ID
- CDR0000644293
- Other IDs
- UCL/05/154, 2005-003888-23, EU-20951, 2005
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24220559
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00971763
- Acronym / sponsor ID
- CDR0000644293
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-GCVP | Experimental | Biological: rituximab, Drug: cyclophosphamide, Drug: gemcitabine hydrochloride, Drug: prednisolone, Drug: vincristine sulfateUp 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximab | Biological | R-GCVP |
| cyclophosphamide | Drug | R-GCVP |
| gemcitabine hydrochloride | Drug | R-GCVP |
| prednisolone | Drug | R-GCVP |
| vincristine sulfate | Drug | R-GCVP |
Primary outcome
Overall response rate
Time frame: End of treatment
3 secondary outcomes
Toxicity
Time frame: End of treatment
Progression-free survival
Time frame: Not specified in protocol
Overall survival
Time frame: Not specified in protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 24220559Fields 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Fields, MD principal investigator
Cancer Research UK
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, cyclophosphamide and gemcitabine hydrochloride in people with Lymphoma, run by University College, London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: End of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00971763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.