LymphomaPhase 3NCT00041210
Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
A Phase 3 study testing bleomycin sulfate, ABVD regimen and Stanford V regimen in people with Lymphoma, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 37 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, ABVD regimen and Stanford V regimen
- Type of treatment
- Surgery or procedure
- How many people
- 850 participants
- Where
- 37 sitesUnited Kingdom
- Study dates
- Oct 2001to not given
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed Hodgkin's lymphoma (any sub-type)
- Stage IB, IIB, IIIA, IIIB, or IV OR
- Stage IA or IIA with locally extensive disease (e.g., bulky mediastinal disease (e.g., greater than 0.33 of the maximum transthoracic diameter on routine chest X-ray or at least 2 extranodal sites of disease))
PATIENT CHARACTERISTICS:
Age:
- 18 to 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Complete blood count normal unless directly due to Hodgkin's lymphoma
Hepatic:
- Hepatic function normal unless directly due to Hodgkin's lymphoma
Renal:
- Renal function normal unless directly due to Hodgkin's lymphoma
Cardiovascular:
- No pre-existing cardiac disease
Pulmonary:
- No pre-existing pulmonary disease
Other:
- Not pregnant
- Fertile patients must use effective contraception during and for six months after study
- HIV negative
- No other prior malignancy except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior therapy for Hodgkin's lymphoma
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United Kingdom37 sites
Monklands General Hospital
Airdrie, Scotland, ML6 0JF
Basildon University Hospital
Basildon, England, SS16 5NL
Royal United Hospital
Bath, England, BA1 3NG
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Saint Richards Hospital
Chichester, England, P019 4SE
Walsgrave Hospital
Coventry, England, CV2 2DX
Craigavon Area Hospital
Craigavon, Northern Ireland, BT63 5QQ
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT
Russells Hall Hospital
Dudley, England, DY1 2HQ
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Hemel Hempstead General
Hemel Hempstead, England, HP2 4AD
Hull Royal Infirmary
Hull, England, HU3 2KZ
King George Hospital
Ilford, Essex, England, IG3 8YB
Lincoln County Hospital
Lincoln, England, LN2 5QY
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Aintree University Hospital
Liverpool, England, L9 7AL
Saint Bartholomew's Hospital
London, England, EC1A 7BE
St. George's Hospital
London, England, SW17 ORE
University College Hospital - London
London, England, WC1E 6AU
James Paget Hospital
Norfolk, England, NR31 6LA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Derriford Hospital
Plymouth, England, PL6 8DH
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD
Oldchurch Hospital
Romford, England, RM7 OBE
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Southampton General Hospital
Southampton, England, SO16 6YD
Staffordshire General Hospital
Stafford, England, ST16 3SA
Royal Marsden - Surrey
Sutton, England, SM2 5PT
South West Wales Cancer Institute
Swansea, Wales, SA2 8QA
Torbay Hospital
Torquay, England, TQ2 7AA
Pinderfields General Hospital
Wakefield, Scotland, WF1 4DG
City Hospital - Birmingham
West Bromwich, England, B71 4HJ
New Cross Hospital
Wolverhampton, England, WV10 0QP
Worthing Hospital
Worthing, England, BN11 2DH
Cancer Care Centre at York Hospital
York, England, Y031 8HE
About this study
Official title: Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
- Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.
All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, ABVD regimen, Stanford V regimen, dacarbazine, doxorubicin hydrochloride
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma, adult mixed cellularity 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
ABVD regimenDrug
Stanford V regimenDrug
dacarbazineDrug
etoposideDrug
mechlorethamine hydrochlorideDrug
prednisoneDrug
vinblastine sulfateDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Secondary outcomes (2)
Overall survival
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peter J. Hoskin, MD, Study chair, Mount Vernon Cancer Centre at Mount Vernon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041210
- Sponsor's protocol ID
- CDR0000069453
- Other IDs
- BNLI-STANFORDV, EU-20206
- Status last verified
- Apr 2009
- First submitted
- 8 Jul 2002
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00041210
- Acronym / sponsor ID
- CDR0000069453
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Mount Vernon Cancer Centre at Mount Vernon HospitalUniversity, hospital or other
- Study start
- Oct 2001
- First posted
- 27 Jan 2003 (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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
- Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.
All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| bleomycin sulfate | Biological | – |
| ABVD regimen | Drug | – |
| Stanford V regimen | Drug | – |
| dacarbazine | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| mechlorethamine hydrochloride | Drug | – |
| prednisone | Drug | – |
| vinblastine sulfate | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Relapse-free survival
2 secondary outcomes
Overall survival
Toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Peter J. Hoskin, MD study chair
Mount Vernon Cancer Centre at Mount Vernon Hospital
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bleomycin sulfate, ABVD regimen and Stanford V regimen in people with Lymphoma, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 37 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Relapse-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2013.