Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00112931 |
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Recruitment Status :
Active, not recruiting
First Posted : June 3, 2005
Last Update Posted : May 10, 2023
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RATIONALE: 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. It is not yet known whether rituximab is more effective than observation in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab to see how well it works compared to observation in treating patients with newly diagnosed stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma with no symptoms.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: rituximab Other: No treatment | Phase 3 |
OBJECTIVES:
Primary
- Compare time to initiation of systemic chemotherapy or radiotherapy in patients with newly diagnosed, previously untreated, asymptomatic stage II-IV non-bulky follicular non-Hodgkin's lymphoma treated with rituximab vs observation only.
Secondary
- Compare the frequency of clinical spontaneous remission in patients treated with these regimens.
- Compare overall and cause-specific survival of patients treated with these regimens.
- Determine the effect of rituximab on complete and partial response in patients treated with subsequent systemic chemotherapy.
- Compare quality of life, in terms of functional well-being and anxiety and depression, of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease grade (1 vs 2 vs 3a), disease stage (II vs III vs IV), and age. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo observation only until disease progression.
- Arm II: Patients receive induction rituximab IV on day 1. Treatment repeats weekly for up to 4 weeks.
- Arm III: Patients receive induction rituximab as in arm II. Patients then receive maintenance rituximab IV once on day 1 of weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100.
In all arms, treatment continues in the absence of unacceptable toxicity or disease progression requiring systemic chemotherapy* or radiotherapy.
NOTE: *Rituximab administration in arm I is considered initiation of systemic chemotherapy
Quality of life is assessed at baseline (before and after randomization), every 2 months for 2 years, and then every 6 months for 2 years.
Patients are followed every 2 months for 2 years and then every 3 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 600 patients (200 per treatment arm) will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | March 2014 |
| Estimated Study Completion Date : | May 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Watch and Wait
Watch and Wait - no treatment
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Other: No treatment |
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Experimental: Arm C Rituximab 4 and Rixuximab Maintenance
4 infusions - 375mg/m2 every 2 months. A single dose of rituximab (375mg/m2 will then be given at 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92 and 100 weeks
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Biological: rituximab |
- Time until initiation of therapy (chemotherapy or radiotherapy) [ Time Frame: Time from randomisation until the first day systemic chemotherapy or radiotherapy is given. If rituximab is given to patients in the watch and wait arm this will be considered as initiation of chemotherapy. ]
- Frequency of clinical spontaneous remission [ Time Frame: From randomisation until the initiation of chemotherapy in the watch and wait arm ]
- Cause specific survival [ Time Frame: Time from randomisation to death from lymphoma or immediate therapy related toxicity ]
- Overall survival [ Time Frame: Time from randomisation to death from any cause. ]
- Response rate at 25 months [ Time Frame: Response at 25 months ]
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed follicular non-Hodgkin's lymphoma
- Diagnosed within the past 3 months
- Grade 1, 2, or 3a disease
- Stage II-IV disease
- No evidence of histological transformation
- Bidimensionally measurable disease by clinical examination or radiography
- Asymptomatic disease without B symptoms or severe pruritus
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Low tumor burden, defined by all of the following criteria:
- Lactic dehydrogenase normal
- Largest nodal or extranodal mass < 7 cm
- No more than 3 nodal sites with a diameter > 3 cm
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No clinically detectable significant serous effusion by chest x-ray
- Clinically non-evident small effusion on CT scan is not considered significant
- Spleen enlargement ≤ 16 cm by CT scan
- Circulating tumor cells < 5,000/mm^3
- No organ compression (i.e., ureteric obstruction)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 10 g/dL
Hepatic
- AST and ALT normal
- Alkaline phosphatase normal
- Bilirubin normal
Renal
- Creatinine < 2 times upper limit of normal (unless due to lymphoma)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after completion of rituximab
- No known HIV positivity
- No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No critical organ failure
- No other immediate life-threatening disease
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 lymphoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112931
Show 72 study locations
| Study Chair: | Kirit Ardeshna | Mount Vernon Cancer Centre at Mount Vernon Hospital |
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT00112931 |
| Other Study ID Numbers: |
CDR0000427312 CRUK-2004-001621-16 EU-20509 ROCHE-CRUK-001621-16 |
| First Posted: | June 3, 2005 Key Record Dates |
| Last Update Posted: | May 10, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma |
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |