An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
- 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
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time until initiation of therapy (chemotherapy or radiotherapy)
Safety Issue:
No
Principal Investigator
Kirit Ardeshna
Investigator Role:
Study Chair
Investigator Affiliation:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Authority:
Unspecified
Study ID:
CDR0000427312
NCT ID:
NCT00112931
Start Date:
September 2004
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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