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Trial record 8 of 82 for:    abp 798

Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01729806
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 20, 2012
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE November 19, 2012
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
Incidence of toxicities according to the Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 12 months ]
Tables will be created to summarize the toxicities and side effects by dose, course, organ and severity.
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4 ( v4) [ Time Frame: Up to 12 months ]
Tables will be created to summarize the toxicities and side effects by dose, course, organ and severity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, antibody dependent cell-mediated cytotoxicity, and kinetics and magnitude of B-cell depletion [ Time Frame: Up to 14 weeks ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Clinical anti-tumor response (complete response and partial response as per international workshop lymphoma response criteria [Cheson 2007]) [ Time Frame: Up to 12 months ]
  • Progression-free survival [ Time Frame: From when the patient started treatment to the time the patient is first recorded as having disease relapse/progression, or to the date of death if the patient dies due to causes other than disease progression, assessed up to 12 months ]
    Progression-free survival will be summarized using Kaplan-Meier plots.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, antibody dependent cell-mediated cytotoxicity (ADCC), and kinetics and magnitude of B-cell depletion [ Time Frame: Day 1 ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, ADCC, and kinetics and magnitude of B-cell depletion [ Time Frame: Day 8 ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, ADCC, and kinetics and magnitude of B-cell depletion [ Time Frame: Day 15 ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, ADCC, and kinetics and magnitude of B-cell depletion [ Time Frame: Day 22 ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, ADCC, and kinetics and magnitude of B-cell depletion [ Time Frame: Week 9 ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, ADCC, and kinetics and magnitude of B-cell depletion [ Time Frame: Week 16 ]
    Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
  • Clinical anti-tumor response (complete response [CR] and partial response [PR] as per International workshop lymphoma response criteria [Cheson 2007]) [ Time Frame: Up to 12 months ]
  • Progression-free survival [ Time Frame: From when the patient started treatment to the time the patient is first recorded as having disease relapse/progression, or to the date of death if the patient dies due to causes other than disease progression, assessed up to 12 months ]
    Progression-free survival will be summarized using Kaplan-Meier plots.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma
Official Title  ICMJE A Phase I Study of Ipilimumab in Combination With Rituximab in Patients With Relapsed/Refractory CD20+ B-Cell Lymphoma
Brief Summary This partially randomized phase I trial studies the side effects and best dose of ipilimumab when given together with rituximab in treating patients with B-cell lymphoma that has returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and rituximab, may interfere with the ability of cancer cells to grow and spread.
Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • CD20 Positive
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
Intervention  ICMJE
  • Biological: Ipilimumab
    Given IV
    Other Names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS-734016
    • MDX-010
    • MDX-CTLA4
    • Yervoy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Rituximab
    Given IV
    Other Names:
    • ABP 798
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • CT-P10
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Rituxan
    • Rituximab Biosimilar ABP 798
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar CT-P10
    • Rituximab Biosimilar GB241
    • Rituximab Biosimilar IBI301
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • Rituximab Biosimilar SAIT101
    • RTXM83
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Biological: Ipilimumab
    • Other: Laboratory Biomarker Analysis
    • Biological: Rituximab
  • Experimental: 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.
    Interventions:
    • Biological: Ipilimumab
    • Other: Laboratory Biomarker Analysis
    • Biological: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)
38
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously treated, histologically confirmed cluster of differentiation (CD)20+ B cell lymphoma; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra nodal biopsies; fine needle aspirates are not acceptable
  • 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 who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01729806
Other Study ID Numbers  ICMJE NCI-2012-02213
NCI-2012-02213 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHI-69
CDR0000743246
NCI# 9197
9197 ( Other Identifier: City of Hope Comprehensive Cancer Center )
9197 ( Other Identifier: CTEP )
P30CA033572 ( U.S. NIH Grant/Contract )
U01CA062505 ( U.S. NIH Grant/Contract )
UM1CA186704 ( U.S. NIH Grant/Contract )
UM1CA186717 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Tuscano City of Hope Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP