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Health Condition(s) or Problem
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Lymphoma
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Lay Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
and either kill them or deliver cancer-killing substances to them without harming normal
cells. It is not yet known whether chemotherapy is more effective with or without rituximab
for relapsed non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab
to see how well they work compared to combination chemotherapy alone in treating patients
with relapsed non-Hodgkin's lymphoma.
(from ClinicalTrials.gov)
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Who can enter the trial
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DISEASE CHARACTERISTICS:
- Histologically or cytologically proven stage III or IV follicular non-Hodgkin's
lymphoma (NHL)
- Relapsed after or no response (no change/progressive disease) to no more than 2
adequate non-anthracycline-containing systemic chemotherapy regimens
- At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR
- At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide,
vincristine, and prednisone) or purine analogues
- Complete or partial remission or no change for at least 4 weeks after completion of
prior therapy OR progression during one of a maximum of 2 prior therapy regimens
- CD20 positive
- At least 1 bidimensionally measurable mass
- No greater than 10,000,000/mL circulating tumor cells
- IgG levels at least 3 g/L
- No low-grade NHL transformed into intermediate- or high-grade NHL
- No symptomatic CNS lymphoma
- No bone marrow involvement only NOTE: A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate",
or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN
Renal:
- Creatinine less than 2.5 times ULN
- BUN less than 2.5 times ULN
Cardiovascular:
- No severe cardiac disease (i.e., severe heart failure requiring symptomatic
treatment)
Pulmonary:
- No severe pulmonary disease
Other:
- No severe neurologic or psychiatric disease
- No severe metabolic disease
- Not pregnant
- Fertile patients must use effective contraception
- No prior malignancy within the past 5 years except nonmelanomatous skin cancer,
carcinoma in situ of the cervix, or other cancer curatively treated with surgical
therapy
- HIV negative
- No uncontrolled asthma or allergy requiring steroids
- No known hypersensitivity or prior anaphylactic reaction to murine proteins or any
component of study drug
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior rituximab
- No prior allogeneic or autologous peripheral blood stem cell transplantation
- Concurrent filgrastim (G-CSF) for stem cell mobilization allowed
Chemotherapy:
- See Disease Characteristics
- No prior anthracyclines or mitoxantrone
- No concurrent chemotherapy for stem cell mobilization
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
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Who cannot enter the trial
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DISEASE CHARACTERISTICS:
- Histologically or cytologically proven stage III or IV follicular non-Hodgkin's
lymphoma (NHL)
- Relapsed after or no response (no change/progressive disease) to no more than 2
adequate non-anthracycline-containing systemic chemotherapy regimens
- At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR
- At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide,
vincristine, and prednisone) or purine analogues
- Complete or partial remission or no change for at least 4 weeks after completion of
prior therapy OR progression during one of a maximum of 2 prior therapy regimens
- CD20 positive
- At least 1 bidimensionally measurable mass
- No greater than 10,000,000/mL circulating tumor cells
- IgG levels at least 3 g/L
- No low-grade NHL transformed into intermediate- or high-grade NHL
- No symptomatic CNS lymphoma
- No bone marrow involvement only NOTE: A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate",
or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN
Renal:
- Creatinine less than 2.5 times ULN
- BUN less than 2.5 times ULN
Cardiovascular:
- No severe cardiac disease (i.e., severe heart failure requiring symptomatic
treatment)
Pulmonary:
- No severe pulmonary disease
Other:
- No severe neurologic or psychiatric disease
- No severe metabolic disease
- Not pregnant
- Fertile patients must use effective contraception
- No prior malignancy within the past 5 years except nonmelanomatous skin cancer,
carcinoma in situ of the cervix, or other cancer curatively treated with surgical
therapy
- HIV negative
- No uncontrolled asthma or allergy requiring steroids
- No known hypersensitivity or prior anaphylactic reaction to murine proteins or any
component of study drug
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior rituximab
- No prior allogeneic or autologous peripheral blood stem cell transplantation
- Concurrent filgrastim (G-CSF) for stem cell mobilization allowed
Chemotherapy:
- See Disease Characteristics
- No prior anthracyclines or mitoxantrone
- No concurrent chemotherapy for stem cell mobilization
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
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What will happen
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Biological; rituximab; Drug; CHOP regimen; Drug; cyclophosphamide; Drug; doxorubicin hydrochloride; Drug; prednisone; Drug; vincristine sulfate
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Primary aim
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Response as assessed by modified Lexcor criteria after induction therapy; Progression-free survival after maintenance therapy
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Secondary Aim
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Overall survival; No; Event-free survival after induction therapy; No; Time to new lymphoma treatment after maintenance therapy; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/EORTC-20981
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Recruitment Status
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Not Recruiting
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Nation
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England, Wales, Northern Ireland, Scotland
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Location
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Aylesbury, Bath, Birmingham, Blackpool, Bournemouth, Bradford, Bristol, Cambridge, Canterbury, Carshalton, Cheltenham, Chester, Colchester, Doncaster, Dudley, Exeter, Gateshead, Grimsby, London, Huntingdon , Ilford, Leeds, Leicester, Liverpool, Merseyside , Middlesbrough, Newcastle upon Tyne, Northwood, Norwich, Oxford, Portsmouth, Prescot, Preston, Reading, Romford, Tunbridge Wells, Salisbury, Scunthorpe, Sheffield , Southampton, Stoke-on-Trent, Sutton, Swansea, Taunton, Torquay, Uxbridge, West Bromwich, Winchester, Wolverhampton, Belfast, Edinburgh, Glasgow, Cardiff, Newport, Rhyl, Chichester, Hull, Kettering, Stafford, Swindon
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