- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320292
Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma
The Asymptomatic Follicular Lymphoma (AFL) Trial: A Phase III Study of Single-Agent Rituximab Immunotherapy Versus Zevalin Radioimmunotherapy for Patients With New, Untreated Follicular Lymphoma Who Are Candidates for Observation
Study Overview
Status
Conditions
- Ann Arbor Stage I Grade 1 Follicular Lymphoma
- Ann Arbor Stage I Grade 2 Follicular Lymphoma
- Ann Arbor Stage III Grade 1 Follicular Lymphoma
- Ann Arbor Stage III Grade 2 Follicular Lymphoma
- Ann Arbor Stage IV Grade 1 Follicular Lymphoma
- Ann Arbor Stage IV Grade 2 Follicular Lymphoma
- Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. Test the hypothesis that a single dose of Zevalin (yttrium Y-90 ibritumomab tiuxetan) rituximab immunotherapy (RIT) will increase the complete remission (CR) rate over that achieved with standard rituximab in patients with untreated asymptomatic follicular lymphoma (FL).
SECONDARY OBJECTIVES:
I. Test the hypothesis that Zevalin RIT will improve progression-free survival. II. Test the hypothesis that Zevalin RIT will improve time to next (any) therapy and time to next chemotherapy.
CORRELATIVE RESEARCH OBJECTIVES:
I. Study the incidence of exon 2 B-cell leukemia/lymphoma 2 protein (bcl2) mutations in patients with asymptomatic follicular lymphoma (AFL).
II. Measure regulatory T cells (Tregs) and tissue monocytes in on-study FL tumor tissue.
III. Measure serum cytokines and vitamin D at on study and month 6. IV. Evaluate beta-2 microglobulin plus lactate dehydrogenase (LDH) score as a prognostic factor.
V. Measure absolute lymphocyte count (ALC), absolute monocyte count (AMC), and ALC/AMC ratio at on study and after treatment.
VI. Compare quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Lymphoma (Lym) between arms.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive rituximab intravenously (IV) on days 1, 8, 15, and 22.
ARM B: Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.
After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months and then every 12 months for 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histological confirmation of follicular lymphoma grades I, II diagnosed within 12 months (365 days) prior to registration; NOTE: the day of biopsy should be used as day 1 of diagnosis for this calculation
- Stage I, II, III, or IV disease; NOTE: stage I disease are eligible only if the disease is not amenable to external beam radiation therapy
- No indication for chemotherapy; candidate for observation
- Measurable disease by tumor imaging with at least one lesion >= 1.5 cm in at least one dimension
- Previously untreated; NOTE: this includes any chemotherapy or immunotherapy or RIT; patients who received corticosteroids for diseases other than lymphoma are eligible as long as prednisone dose is =< 10 mg/day
Low tumor burden as defined by Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria (2):
- No tumor mass (nodal or extranodal) >= 7 cm in one dimension on computed tomography (CT)
- Fewer than 3 (2 or less) nodal masses > 3 cm
- No systemic or B symptoms
- No splenomegaly greater than 16 cm by CT scan
- No risk of organ compression - ureteral, orbital, neurological, gastrointestinal
- No leukemic phase (> 5.0 x 10^9/L circulating FL cells in the blood as detected by complete blood count [CBC] with differential and smear)
- No cytopenias - absolute neutrophil count (ANC) < 1000 or platelets < 100,000
Meet standard criteria for RIT:
- < 25% marrow involvement with FL
- No evidence of myelodysplasia
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =< 28 days prior to registration
- Platelet count >= 100,000/mm^3 =< 28 days prior to registration
- Hemoglobin > 10.0 g/dL =< 28 days prior to registration
- Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< ULN =< 28 days prior to registration
- Alkaline phosphatase =< 3 x ULN =< 28 days prior to registration
- Aspartate transaminase (AST) =< 3 x ULN
- Creatinine =< 2 x ULN =< 28 days prior to registration
- Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Provide informed written consent
- Willing to travel to a radioimmunotherapy site for Zevalin, if necessary
- Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study); Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
- Willing to provide blood samples at baseline for correlative research purposes and tissue for central pathology review
- < 25% bone marrow involvement of cellular marrow with lymphoma as determined by bilateral bone marrow aspirate and biopsy; NOTE: the percent involvement should be estimated by the hematopathologist using all of the biopsy material
- Has insurance coverage or is willing to pay for protocol therapy (rituximab x 4 or Zevalin x 1)
Exclusion Criteria:
Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception for at least three months after completing study treatment
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- NOTE: These patients are excluded because it is unknown what effects prolonged B-cell depletion will have on these patient's immune system
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent that would be considered as a treatment for the lymphoma
- Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment and would interfere with follow-up assessments through year 5
- Presence of central nervous system (CNS) lymphoma
- Known to have lymphoma related to HIV or acquired immune deficiency syndrome (AIDS)
- Abnormal renal function (serum creatinine > 2 x ULN)
- Received prior external beam radiation therapy for another reason to > 25% of active bone marrow
- Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives
- Major surgery other than diagnostic surgery =< 4 weeks prior to registration
- Any evidence of myelodysplastic syndrome or marrow chromosomal changes suggesting myelodysplasia (-7, -5 etc)
- Corticosteroid therapy at the time the patient enters the protocol; NOTE: patients using prednisone or its equivalent for adrenal failure or using =< 10 mg of prednisone/day for other benign causes are accepted
- Follicular grades IIIA or IIIB are not eligible
- Marrow cellularity =< 15% (as determined on all bone marrow samples)
Seropositive for or active viral infection with hepatitis B virus (HBV):
- Hepatitis B surface antigen (HBsAg) positive
- HBsAg negative, anti-hepatitis B surface antibody (HBs) positive and/or anti-hepatitis B core antibody (HBc) positive and detectable viral deoxyribonucleic acid (DNA)
Notes:
- Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA negative are eligible
Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
- Active infection with hepatitis C virus (HCV)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A (rituximab)
Patients receive rituximab IV on days 1, 8, 15, and 22.
|
Ancillary studies
Other Names:
Given IV
Other Names:
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Experimental: Arm B (rituximab, yttrium Y-90 ibritumomab tiuxetan)
Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.
|
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response (CR) Rate at the 6-month Disease Assessment
Time Frame: 6 months
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Will be compared between the two arms.
The percentage of patients in each response category (e.g., CR, partial remission, stable disease, relapse/progressive disease) will also be tabulated by arm.
The proportion of patients who have a CR at 6 months will be evaluated and compared between the two treatment regimens using a two-sided alpha=0.05
continuity corrected Cochran-Mantel-Haenszel test with stratification factors.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: Time from registration to the earliest date documentation of disease progression or death due to any cause, assessed up to 5 years
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The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier within each arm and compared between the arms using a logrank test.
The progression-free survival rates at 3 years and 5 years will be estimated in each arm.
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Time from registration to the earliest date documentation of disease progression or death due to any cause, assessed up to 5 years
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Time to Any Therapy (TTNT)
Time Frame: Time from registration to the date of initiation of any treatment for follicular lymphoma, assessed up to 5 years
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The distribution of time to any therapy will be estimated using the method of Kaplan-Meier within each arm and compared between the arms using a log-rank test.
The percentage of patients free of any therapy at 3 years and 5 years will be estimated in each arm.
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Time from registration to the date of initiation of any treatment for follicular lymphoma, assessed up to 5 years
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Time to Chemotherapy (TTC)
Time Frame: Time from registration to the date of initiation of chemotherapy for follicular lymphoma, assessed up to 5 years
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The distribution of time to chemotherapy will be estimated using the method of Kaplan-Meier within each arm and compared between the arms using a log-rank test.
The percentage of patients free of chemotherapy at 3 years and 5 years will be estimated in each arm.
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Time from registration to the date of initiation of chemotherapy for follicular lymphoma, assessed up to 5 years
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Incidence of Adverse Events
Time Frame: Up to 5 years
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Assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Rates of individual adverse events (grade 3 and higher) will be compared between arms using a Fisher's exact test.
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Up to 5 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Exon 2 bcl2 Mutations
Time Frame: Baseline
|
Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
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Baseline
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Change in Quantification of Tissue Tregs and Tissue Monocytes on Study Tumor Biopsies
Time Frame: Baseline to 6 months
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Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
For values collected at more than one time point, changes over time will be evaluated using paired-t-tests.
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Baseline to 6 months
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Change in Serum Cytokines
Time Frame: Baseline to 6 months
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Each cytokine will be evaluated in reference to normal controls and levels will be categorized as normal, elevated, or suppressed.
Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
For values collected at more than one time point, changes over time will be evaluated using paired-t-tests.
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Baseline to 6 months
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Change in Vitamin D
Time Frame: Baseline to 6 months
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Vitamin D level will be categorized as normal (sufficient) vs. abnormal (insufficient).
Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
For values collected at more than one time point, changes over time will be evaluated using paired-t-tests.
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Baseline to 6 months
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Beta-2 Microglobulin (B2m) Plus LDH Score
Time Frame: Baseline
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Will be categorized at baseline as low risk (both factors =< 150% ULN), intermediate risk (one factor =< 150% IULN and the other factor > 150% ULN), or high risk (both factors > 150% IULN).
The prognostic value of B2m plus LDH score in relation to PFS will be evaluated using Kaplan-Meier methods and log-rank statistics.
Will be evaluated in each arm independently and may also be compared between the two arms.
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Baseline
|
Change in Absolute Lymphocyte Count (ALC)
Time Frame: Baseline to 6 months
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Both the absolute and relative change will be summarized for each measure.
Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
For values collected at more than one time point, changes over time will be evaluated using paired-t-tests.
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Baseline to 6 months
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Change in Absolute Monocyte Count (AMC) Ratio
Time Frame: Baseline to 6 months
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Both the absolute and relative change will be summarized for each measure.
Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
For values collected at more than one time point, changes over time will be evaluated using paired-t-tests.
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Baseline to 6 months
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Change in ALC/AMC Ratio
Time Frame: Baseline to 6 months
|
Both the absolute and relative change will be summarized for each measure.
Will be evaluated in each arm independently and may also be compared between the two arms.
Values may be investigated with respect to response (CR vs. less than CR) chi-square tests.
Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).
For values collected at more than one time point, changes over time will be evaluated using paired-t-tests.
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Baseline to 6 months
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Quality of Life (QOL)
Time Frame: Up to 5 years
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As assessed by Functional Assessment of Cancer Therapy (FACT).
Mean FACT will be graphically presented by arm using a mean plot with standard deviation error bars including all available data with patients according to the randomized treatment assignment.
Baseline characteristics will be compared between arms within the subject of patients who provide QOL data at one or more time points using t-tests for continuous variables and chi-squared tests for categorical variables.
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Up to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas E. Witzig, M.D., Mayo Clinic in Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Rituximab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- LS138D (Other Identifier: Mayo Clinic in Rochester)
- P30CA015083 (U.S. NIH Grant/Contract)
- NCI-2014-02476 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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