LymphomaPhase 3IDEC-C2B8NCT00064116
Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma
A Phase 3 study testing rituximab and CHOP regimen in people with Lymphoma, run by NCIC Clinical Trials Group at 25 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab and CHOP regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 25 sitesCanada
- Study dates
- 8 May 2001to 16 Jan 2014
- 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 diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification
- Diagnosed within the past 6 weeks
- CD20+ disease
- Ann Arbor stage II, III, or IV disease or stage I bulky disease
- International Prognostic Index (IPI) score of 0 or 1
- Score 0 defined by all of the following:
- Stage I or II disease
- ECOG performance status of 0 or 1
- Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)
- Score 1 defined by 1 of the following:
- Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN
- Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN
- Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN
- Previously untreated disease
- Mediastinal B-cell lymphoma allowed
- No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies
- No transformed lymphoma
- No primary CNS lymphoma
- No primary gastrointestinal (MALT) lymphoma
- No post-transplant lymphoproliferative disorder
PATIENT CHARACTERISTICS:
Age
- 18 to 60
Performance status
- See Disease Characteristics
- ECOG 0-3
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2.0 mg/dL*
- Transaminases no greater than 3 times normal*
- No active chronic hepatitis B or C infection NOTE: *Unless related to lymphoma
Renal
- Creatinine no greater than 2 times normal* NOTE: *Unless related to lymphoma
Cardiovascular
- No myocardial infarction within the past 6 months
- No uncompensated heart failure
- No dilatative cardiomyopathy
- No coronary heart disease with ST segment depression on ECG
- No severe uncompensated hypertension
Pulmonary
- No chronic lung disease with hypoxemia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No known allergic reactions against foreign proteins
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No concurrent disease that would preclude study treatment
- No active infections requiring systemic antibiotics or antiviral medications
- No severe uncompensated diabetes mellitus
- No clinical signs of cerebral dysfunction
- No severe psychiatric disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior murine antibodies
Chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy
Surgery
- Not specified
Other
- No prior lymphoma-specific treatment
- More than 12 weeks since prior participation in another clinical trial
- No prior participation in this study
- No other concurrent study medication
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Canada25 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, C1A 8T5
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
London Regional Cancer Program
London, Ontario, N6A 4L6
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Ottawa Health Research Institute - General Division
Ottawa, Ontario, K1H 8L6
CHA-Hopital Du St-Sacrement
Québec, Quebec, G1S 4L8
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Niagara Health System
St. Catharines, Ontario, L2R 7C6
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, AIB 3V6
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Univ. Health Network-The Toronto General Hospital
Toronto, Ontario, M5G 2C4
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Trillium Health Centre - West Toronto
Toronto, Ontario, M9C 1A5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab
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 combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma treated with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy with vs without rituximab.
- Compare the tumor control, progression rate, and complete remission rate in patients treated with these regimens.
- Compare the disease-free and overall survival rate of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive 1 of the following chemotherapy regimens according to participating country:
- CHOP: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- CHOEP-21: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- PMitCEBO: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; vincristine IV and bleomycin IV on day 8; and oral prednisolone daily during weeks 1-4 and every other day during week 5. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- MACOP-B: Patients receive cyclophosphamide IV and doxorubicin IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV and vincristine IV on days 8, 36, and 64; bleomycin IV and vincristine IV on days 22, 50, and 78; and oral or intramuscular prednisone on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive arm I regimens (according to participating country) and rituximab as follows:
- CHOP and rituximab: Patients receive CHOP as in arm I and rituximab IV on day 1.
- CHOEP-21 and rituximab: Patients receive CHOEP-21 as in arm I and rituximab IV on day 1.
- PMitCEBO and rituximab: Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4; on day 8 during courses 2 and 5; and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy.
- MACOP-B and rituximab: Patients receive MACOP-B as in arm I and rituximab IV on days 1, 22, 43, 64, 85, and 106.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years.
- Conditions
- Lymphoma
- Being tested
- rituximab, CHOP regimen
- 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
Rituximab 375 mg/m² i.v. day 1
CHOP regimenDrug
Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6
| Study group | Role | What they receive |
|---|---|---|
| Arm A: CHOP-21 | Active comparator | Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6 Receives: Drug: CHOP regimen |
| Arm B: CHOP-21 + Rituximab | Active comparator | Rituximab 375 mg/m² i.v. day 1* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6 Receives: Biological: rituximab; Drug: CHOP regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF) at 3 years
Measured: 3 years
Secondary outcomes (7)
Complete remission rate after completion of treatment
Measured: 3 years
Overall survival at 3 years
Measured: 3 years
Tumor control measured by TTF with non-tumor events censored at 3 years
Measured: 3 years
Disease-free survival (DFS) measured by TTF after an event during and directly after treatment at 3 years
Measured: 3 years
Progression rate determined by dividing the number of patients with disease progression by number of patients with evaluable outcome at 3 years
Measured: 3 years
Time to progression measured at 3 years
Measured: 3 years
Toxicity assessed by NCI CTC v2.0 after completion of treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2003 (estimated)
- Study start8 May 2001
- Primary completionDec 2010
- Study completion16 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kevin Imrie, MD, Study chair, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064116
- Sponsor's protocol ID
- LY9
- Other IDs
- CAN-NCIC-LY9, ROCHE-CAN-NCIC-LY9, MINT-M39045, CDR0000309053
- Acronym
- IDEC-C2B8
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2003
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfreundschuh M, Ho AD, Cavallin-Stahl E, Wolf M, Pettengell R, Vasova I, Belch A, Walewski J, Zinzani PL, Mingrone W, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Corrado C, Scheliga A, Loeffler M, Kuhnt E; MabThera International Trial (MInT) Group. Prognostic significance of maximum tumour (bulk) diameter in young patients with good-prognosis diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an exploratory analysis of the MabThera International Trial Group (MInT) study. Lancet Oncol. 2008 May;9(5):435-44. doi: 10.1016/S1470-2045(08)70078-0. Epub 2008 Apr 8.
PubMed 18400558Pfreundschuh M, Trumper L, Osterborg A, Pettengell R, Trneny M, Imrie K, Ma D, Gill D, Walewski J, Zinzani PL, Stahel R, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Lehtinen T, Lopez-Guillermo A, Corrado C, Scheliga A, Milpied N, Mendila M, Rashford M, Kuhnt E, Loeffler M; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91. doi: 10.1016/S1470-2045(06)70664-7.
PubMed 16648042
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab
- ClinicalTrials.gov ID
- NCT00064116
- Acronym / sponsor ID
- IDEC-C2B8 / LY9
- 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 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 8 May 2001 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- 16 Jan 2014 (actual)
- First posted
- 9 Jul 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. 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 combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma treated with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy with vs without rituximab.
- Compare the tumor control, progression rate, and complete remission rate in patients treated with these regimens.
- Compare the disease-free and overall survival rate of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive 1 of the following chemotherapy regimens according to participating country:
- CHOP: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- CHOEP-21: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- PMitCEBO: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; vincristine IV and bleomycin IV on day 8; and oral prednisolone daily during weeks 1-4 and every other day during week 5. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- MACOP-B: Patients receive cyclophosphamide IV and doxorubicin IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV and vincristine IV on days 8, 36, and 64; bleomycin IV and vincristine IV on days 22, 50, and 78; and oral or intramuscular prednisone on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive arm I regimens (according to participating country) and rituximab as follows:
- CHOP and rituximab: Patients receive CHOP as in arm I and rituximab IV on day 1.
- CHOEP-21 and rituximab: Patients receive CHOEP-21 as in arm I and rituximab IV on day 1.
- PMitCEBO and rituximab: Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4; on day 8 during courses 2 and 5; and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy.
- MACOP-B and rituximab: Patients receive MACOP-B as in arm I and rituximab IV on days 1, 22, 43, 64, 85, and 106.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: CHOP-21 | Active comparator | Drug: CHOP regimenCyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6 |
| Arm B: CHOP-21 + Rituximab | Active comparator | Biological: rituximab, Drug: CHOP regimenRituximab 375 mg/m² i.v. day 1* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6 |
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 |
|---|---|---|
| rituximabRituximab 375 mg/m² i.v. day 1 | Biological | Arm B: CHOP-21 + Rituximab |
| CHOP regimenCyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6 | Drug | Arm A: CHOP-21, Arm B: CHOP-21 + Rituximab |
Primary outcome
Time to treatment failure (TTF) at 3 years
Time frame: 3 years
7 secondary outcomes
Complete remission rate after completion of treatment
Time frame: 3 years
Overall survival at 3 years
Time frame: 3 years
Tumor control measured by TTF with non-tumor events censored at 3 years
Time frame: 3 years
Disease-free survival (DFS) measured by TTF after an event during and directly after treatment at 3 years
Time frame: 3 years
Progression rate determined by dividing the number of patients with disease progression by number of patients with evaluable outcome at 3 years
Time frame: 3 years
Time to progression measured at 3 years
Time frame: 3 years
Toxicity assessed by NCI CTC v2.0 after completion of treatment
Time frame: 3 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 1 Apr 2020.
- Results publication: PubMed 18400558Pfreundschuh M, Ho AD, Cavallin-Stahl E, Wolf M, Pettengell R, Vasova I, Belch A, Walewski J, Zinzani PL, Mingrone W, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Corrado C, Scheliga A, Loeffler M, Kuhnt E; MabThera International Trial (MInT) Group. Prognostic significance of maximum tumour (bulk) diameter in young patients with good-prognosis diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an exploratory analysis of the MabThera International Trial Group (MInT) study. Lancet Oncol. 2008 May;9(5):435-44. doi: 10.1016/S1470-2045(08)70078-0. Epub 2008 Apr 8.
- Results publication: PubMed 16648042Pfreundschuh M, Trumper L, Osterborg A, Pettengell R, Trneny M, Imrie K, Ma D, Gill D, Walewski J, Zinzani PL, Stahel R, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Lehtinen T, Lopez-Guillermo A, Corrado C, Scheliga A, Milpied N, Mendila M, Rashford M, Kuhnt E, Loeffler M; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91. doi: 10.1016/S1470-2045(06)70664-7.
- Individual participant dataSharing planned: No
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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.
Kevin Imrie, MD study chair
Toronto Sunnybrook Regional Cancer Centre
25 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 rituximab and CHOP regimen in people with Lymphoma, run by NCIC Clinical Trials Group at 25 sites in Canada.
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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Canada. 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?
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?
Time to treatment failure (TTF) at 3 years (time frame: 3 years). 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 NCT00064116, which also lists 2 linked publications.
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 1 Apr 2020.