LymphomaPhase 2NCT00079105

A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

A Phase 2 study testing bleomycin sulfate, cyclophosphamide and etoposide in people with Lymphoma, run by Newcastle-upon-Tyne Hospitals NHS Trust at 54 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. Read more about this study

Who is it for?: Ages 60 to 120 years
Conditions the study is for: Lymphoma
What is being tested?: bleomycin sulfate, cyclophosphamide and etoposide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 54 sitesin 2 countries
Study dates: Jan 2004to Dec 2010
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 60 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.
No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.

Who cannot join

Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age <60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.
Unable to give informed consent.

Trial locations and contacts

54 sites in 2 countries.

Country

City, postcode or hospital

54 sites in 2 countries

United Kingdom53 sites

Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Monklands General Hospital
Airdrie, Scotland, ML6 0JF
Wansbeck General Hospital
Ashington, England, NE63 9JJ
Barnet General Hospital
Barnet, Hertfordshire, EN5 3DJ
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Royal United Hospital
Bath, England, BA1 3NG
Good Hope Hospital
Birmingham, England, B75 7RR
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Bradford Royal Infirmary
Bradford, England, BD9 6RJ
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG
Cumberland Infirmary
Carlisle, England, CA2 7HY
Saint Richards Hospital
Chichester, England, P019 4SE
University Hospital of North Durham
Durham, England, DH1 5TW
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Queen Elizabeth Hospital
Gateshead-Tyne and Wear, England, NE9 6SX
Medway Maritime Hospital
Gillingham Kent, England, ME7 5NY
Western Infirmary
Glasgow, Scotland, G11 6NT
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
Harrogate District Hospital
Harrogate, England, HG2 7SX
Hull Royal Infirmary
Hull, England, HU3 2KZ
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Ipswich Hospital
Ipswich, England, IP4 5PD
Airedale General Hospital
Keighley, England, BD20 6TD
Kettering General Hosptial
Kettering, Northants, England, NNI6 8UZ
Leeds General Infirmary
Leeds, England, LS1 3EX
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
University College Hospital - London
London, England, NW1 2PG
Maidstone Hospital
Maidstone, England, ME16 9QQ
Manchester Royal Infirmary
Manchester, England, M13 9WL
Christie Hospital
Manchester, England, M20 4BX
Trafford General Hospital
Manchester, England, M31 3SL
James Cook University Hospital
Middlesbrough, England, TS4 3BW
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, NE2 4HH
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
North Tyneside Hospital
North Shields, England, NE29 8NH
Northampton General Hospital
Northampton, England, NN1 5BD
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Royal Alexandra Hospital
Paisley, Scotland
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Pembury Hospital
Royal Tunbridge Wells, Kent, England, TN2 4QJ
Royal Hallamshire Hospital
Sheffield, England, S1O 2JF
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
South Tyneside District Hospital
South Shields, England, NE34 0PL
Southampton General Hospital
Southampton, England, SO16 6YD
Staffordshire General Hospital
Stafford, England, ST16 3SA
University Hospital of North Staffordshire
Stoke-On-Trent Staffs, England, ST4 6QG
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
West Cumberland Hospital
Whitehaven, England, CA28 8JG
Wishaw General Hospital
Wishaw, Scotland, ML2 0DP
Cancer Care Centre at York Hospital
York, England, Y031 8HE

Other trials in United Kingdom

Germany1 site

Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924

Other trials in Germany

About this study

Official title: A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.

Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

Conditions: Lymphoma
Being tested: bleomycin sulfate, cyclophosphamide, etoposide, mitoxantrone hydrochloride, prednisolone
Keywords: stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Medical subject headings: Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bleomycin sulfateBiological
Also called Blenoxane
Treatment
cyclophosphamideDrug
Also called Cytoxan
Treatment
etoposideDrug
Also called Eposin, Etopophos, Vepesid
Treatment
mitoxantrone hydrochlorideDrug
Also called Novantrone
Treatment
prednisoloneDrug
Also called Flo-Pred, Pediapred, Orapred
Treatment
procarbazine hydrochlorideDrug
Also called Matulane
Treatment
vinblastine sulfateDrug
Also called Vincristine
Treatment

Study groups in NCT00079105
Study group	Role	What they receive
Treatment	Active comparator	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Receives: Biological: bleomycin sulfate; Drug: cyclophosphamide; Drug: etoposide; Drug: mitoxantrone hydrochloride; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vinblastine sulfate
Registration	No intervention	Registration, without treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-free survival by routine imaging
Measured: 6 month intervals

Secondary outcomes (1)

Overall survival by routine imaging
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Dec 2010

First posted9 Mar 2004 (estimated)
Study startJan 2004
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LymphomaStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00079105
Sponsor's protocol ID: CDR0000354225
Other IDs: UON-SHIELD, EU-20346
Status last verified: Mar 2017
First submitted: 8 Mar 2004
Last updated: 30 Mar 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No: No IPD were shared, nor will be, for this trial.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT00079105
Acronym / sponsor ID: CDR0000354225
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
Study start: Jan 2004
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 9 Mar 2004 (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.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.

Detailed description

OBJECTIVES:

Primary

Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.

Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment	Active comparator	Biological: bleomycin sulfate, Drug: cyclophosphamide, Drug: etoposide, Drug: mitoxantrone hydrochloride, Drug: prednisolone, Drug: procarbazine hydrochloride, Drug: vinblastine sulfateTreatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Registration	No intervention	–Registration, without treatment

Who may qualify

Ages: 60 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.
No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.

Key exclusion criteria (2 listed)

Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age <60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.
Unable to give informed consent.

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
bleomycin sulfateAlso: BlenoxaneTreatment	Biological	Treatment
cyclophosphamideAlso: CytoxanTreatment	Drug	Treatment
etoposideAlso: Eposin, Etopophos, VepesidTreatment	Drug	Treatment
mitoxantrone hydrochlorideAlso: NovantroneTreatment	Drug	Treatment
prednisoloneAlso: Flo-Pred, Pediapred, OrapredTreatment	Drug	Treatment
procarbazine hydrochlorideAlso: MatulaneTreatment	Drug	Treatment
vinblastine sulfateAlso: VincristineTreatment	Drug	Treatment

Primary outcome

Disease-free survival by routine imaging
Time frame: 6 month intervals

1 secondary outcome

Overall survival by routine imaging
Time frame: 5 years

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 30 Mar 2017.
Individual participant dataSharing planned: No. No IPD were shared, nor will be, for this trial.

Related trials for Lymphoma

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

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.

Stephen J. Proctor, MD study chair

University of Newcastle Upon-Tyne

Helen H. Lucraft, MD study director

Northern Centre for Cancer Treatment at Newcastle General Hospital

Katrina M. Wood, MD study director

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

54 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bleomycin sulfate, cyclophosphamide and etoposide in people with Lymphoma, run by Newcastle-upon-Tyne Hospitals NHS Trust at 54 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United Kingdom, Germany. 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?

Disease-free survival by routine imaging (time frame: 6 month intervals). 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 NCT00079105.

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 30 Mar 2017.