Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma
NCT ID: NCT01729806
Last Updated: 2018-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2012-11-19
2018-03-30
Brief Summary
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Detailed Description
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I. To determine a recommended phase II dose for ipilimumab in combination with rituximab.
SECONDARY OBJECTIVES:
I. To obtain preliminary information on the effect of adding ipilimumab to rituximab in regard to: immune response; clinical anti-tumor response/overall remission rate (ORR) (complete remission + partial remission); progression free survival (PFS).
OUTLINE: This is a dose-escalation study of ipilimumab followed by a randomized study.
PART I:
INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes once every 3 weeks for 12 weeks and rituximab IV over 2-6 hours once weekly for 4 weeks.
MAINTENANCE: Patients receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year.
PART II: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (ipilimumab and rituximab)
Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ipilimumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Rituximab
Given IV
Arm B (ipilimumab and rituximab)
Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ipilimumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Rituximab
Given IV
Interventions
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Ipilimumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Rituximab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
* Able to adhere to the study visit schedule and other protocol requirements
* Karnofsky \>= 70%
* Life expectancy expected to be greater than 3 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,000/mcL
* Platelets \>= 50,000/mcL
* Total bilirubin =\< 2.0 x institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
* Serum creatinine =\< 2.0 x upper limit of normal OR calculated creatinine clearance \>= 30 ml/min/1.73 M\^2 by the modified Cockcroft and Gault formula OR creatinine clearance \>= 30 mL/min obtained from a 24-hour urine collection
* At least one measurable lesion according to international workshop lymphoma response criteria; there must be measurable lymphadenopathy to follow with serial exam and/or imaging
* All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
* Patients must have evidence of progression of disease during or after last treatment
* Submission of original biopsy for review and verification by participating center hematopathologist
* Disease free of prior malignancies for \>= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
Exclusion Criteria
* Patients with a history of prior treatment with ipilimumab
* Patients with a history of prior treatment with an anti-programmed cell death (PD) 1 antibody, CD137 agonist or other immune activating therapy such as anti-CD 40 antibody are excluded unless 5 half-lives of the agent (minimum of 8 weeks) have intervened since the therapy; patients who have received prior vaccine therapy are eligible
* Patients who are receiving any other investigational agents
* Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)
* Patients with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody
* Patients with known uncontrolled brain metastases are excluded; however, patients with stable brain disease (off corticosteroids) at least 2 weeks after completion of appropriate therapy for their brain metastases are eligible
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab
* Patients on systemic corticosteroids (except for patients on stable doses of hormone replacement therapy such as hydrocortisone), or other immunosuppressants (e.g., infliximab, mycophenolate mofetil) are excluded
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections are excluded
* Pregnant women are excluded from this study
* HIV-positive patients on combination antiretroviral therapy are ineligible
* Rituximab within six weeks
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Joseph Tuscano
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2012-02213
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHI-69
Identifier Type: -
Identifier Source: secondary_id
CDR0000743246
Identifier Type: -
Identifier Source: secondary_id
NCI# 9197
Identifier Type: -
Identifier Source: secondary_id
9197
Identifier Type: OTHER
Identifier Source: secondary_id
9197
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02213
Identifier Type: -
Identifier Source: org_study_id
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