Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Rituximab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Immunologic Factors

Patients undergo radiation therapy five days a week for 2.5 weeks (12 treatments) and receive rituximab IV over 4-6 hours weekly with the start of radiation for 4 weeks and then every 2 months for up to 4 additional doses in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.

Clinical Observation

Radiation Therapy

Bouthaina S. Dabaja

Bouthaina S Dabaja

This randomized phase I/II trial studies radiation therapy and rituximab in treating patients with stage I-II grade 1 or grade 2 follicular lymphoma. Radiation therapy uses high energy x-rays to kill cancer cells. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy with rituximab may kill more cancer cells.

PRIMARY OBJECTIVE:

I. To determine if rituximab concurrently with radiation followed by maintenance rituximab offers a superior benefit over radiation alone. Specifically looking at the progression free survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo radiation therapy five days a week for 2.5 weeks (12 treatments) and receive rituximab intravenously (IV) over 4-6 hours weekly with the start of radiation for 4 weeks and then every 2 months for up to 4 additional doses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.

After completion of study treatment, patients are followed up at 3 and 6 months, every 6 months for 2 years, yearly for 3 years, and then every 2 years for 10 years.

Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma

Randomized Trial of Radiation Therapy With and Without Rituximab for Patients With Stage I II Follicular Lymphoma Grade I/II

The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between two different patient groups. The chi-square test or the Fisher's exact test will then be applied to assess the association between two categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate. Kaplan-Meier survival curves will also be constructed.

Estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. The Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Immunomodulating Agents

Patients receive rituximab IV on days 1, 8, 15, and 22.

Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.

Quality-of-Life Assessment

Yttrium Y-90 Ibritumomab Tiuxetan

Thomas E. Witzig, M.D.

This phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to see how well they work compared to rituximab alone in treating patients with untreated follicular lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radioactive substances linked to monoclonal antibodies can bind to cancer cells and give off radiation which may help kill cancer cells. It is not yet known whether rituximab works better with or without yttrium Y-90 ibritumomab tiuxetan in treating follicular lymphoma.

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.

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

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Mayo Clinic

Arm A (Rituximab)

Yttrium Y-90 Ibritumomab Tiuxetan: Given IV

Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan)

Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\>

\> Rituximab: Given IV

Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\>

\> Quality-of-Life Assessment: Ancillary studies\>

\> Rituximab: Given IV\>

\> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV

Total

Age, Continuous

18-29

30-39

40-49

50-59

60-69

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Normal

Abnormal

Beta-2 Microglobulin

< 3 months

3-12 months

Time from Diagnosis to Registration

Lactate Dehydrongenase

Follicular Lymp Grade 1

Follicular Lymp Grade 2

An indolent (slow-growing) type of non-Hodgkin lymphoma marked by enlarged lymph nodes and a mix of large cells and small cells that have cleaved (u-shaped) nuclei. Grade 1 is better, Grade 2 is worse.

NHL Type

Low Risk

Intermediate Risk

High Risk

FLIPI2 score

Dr. Thomas E Witzig

Complete Response (CR) Rate at the 6-month Disease Assessment

Progression-free Survival (PFS)

Time to Any Therapy (TTNT)

Time to Chemotherapy (TTC)

Incidence of Adverse Events

Incidence of Exon 2 bcl2 Mutations

Change in Quantification of Tissue Tregs and Tissue Monocytes on Study Tumor Biopsies

Change in Serum Cytokines

Change in Vitamin D

Beta-2 Microglobulin (B2m) Plus LDH Score

Change in Absolute Lymphocyte Count (ALC)

Change in Absolute Monocyte Count (AMC) Ratio

Change in ALC/AMC Ratio

Quality of Life (QOL)

Overall Study

Lymphoma, Mantle-Cell

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

B-cell Lymphoma

Mantle Cell Lymphoma

Marginal Zone Lymphoma

Indolent B Cell Lymphoma

Orbital Lymphoma

Patients undergo two fractions of low dose orbital EBRT on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.

External Beam Radiation Therapy

Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.

Orbital Radiation

Chelsea C Pinnix, M D

This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of ultra low dose 4 Gray (Gy) orbital radiation, measured as local orbital control (i.e. local control within the radiation field), in patients with limited and advanced stage low grade B lymphocyte (B cell) lymphoma and mantle cell lymphoma involving the ocular adnexa.

II. To evaluate the efficacy of ultra low dose 4 Gy orbital radiation, measured as complete response, in patients with limited and advanced stage low grade B cell lymphoma and mantle cell lymphoma involving the ocular adnexa.

III. To evaluate the acute and chronic toxicity of radiation to the orbit.

SECONDARY OBJECTIVE:

I. To determine if dynamic contrast enhanced magnetic resonance imaging can predict response to ultra low dose radiation therapy.

OUTLINE:

Patients undergo low dose orbital external beam radiation therapy (EBRT) on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.

After completion of study treatment, patients are followed up every 3-4 months for 6-8 months, every 6-12 months for up to 2 years, and then periodically thereafter.

Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma

Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma

Local orbital event will be estimated using the Kaplan-Meier method.

Response rate will be estimated along with 95% confidence intervals.

OS will be estimated using the Kaplan-Meier method.

Toxicity data will be summarized by frequency tables.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma	NCT01473628	Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage...	Clinical Observ... Radiation Thera... Rituximab	18 Years -	M.D. Anderson Cancer Center
Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma	NCT02320292	Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage...	Quality-of-Life... Rituximab Yttrium Y-90 Ib...	18 Years -	Mayo Clinic
Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma	NCT02320292	Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage...	Quality-of-Life... Rituximab Yttrium Y-90 Ib...	18 Years -	Mayo Clinic
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma	NCT02494700	Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ocular Adnexal ... Ocular Adnexal ... Orbit Lymphoma	External Beam R... Orbital Radiati...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ann arbor stage i grade 1 follicular lymphoma