MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma
Phase I/II Study of Anti-CTLA-4 Monoclonal Antibody (MDX-010) in B-cell Non-Hodgkin's Lymphoma
5 other identifiers
interventional
18
1 country
1
Brief Summary
Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop cancer cells from growing. This phase I/II trial is studying the side effects and best dose of MDX-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2004
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 4, 2004
CompletedFirst Posted
Study publicly available on registry
August 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
October 19, 2012
CompletedMay 30, 2014
December 1, 2012
4.1 years
August 4, 2004
May 11, 2012
May 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Overall Confirmed Responses(Complete Response or Partial Response)
Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
From registration to month 7
Secondary Outcomes (7)
Time to Progression (Phase 2)
From registration to progression (up to 2 years)
Overall Survival (Phase 2)
From registration to death (up to 2 years)
Duration of Response (Phase 2)
From response to progression (up to 2 years)
Mean Change in % of CD3+CD4+ for Marker HLA-DR+
Before treatment to 1 month after therapy initiation
Mean Change in % of CD3+CD4- for Marker HLA-DR+
Before treatment to 1 month after therapy initiation
- +2 more secondary outcomes
Study Arms (1)
Treatment (ipilimumab)
EXPERIMENTALPHASE I: Patients receive MDX-010 IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive MDX-010 as in phase I at the MTD.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Histologic proof of recurring or residual follicular B-cell non-Hodgkin's lymphoma (grade I or II), by Revised European American Lymphoma Classification (REAL) or World Health Organization (WHO) classifications which has relapsed or persisted after 3 or fewer conventional therapies, including chemotherapy or monoclonal antibody therapy; note: all patients with previously treated B-cell lymphomas of any histology with the exception of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) are eligible
- Tumor measurable by computed tomography (CT) scans (at least one pathologic node measuring 2.0 x 2.0 cm, or 2 nodes measuring \> 1.5 x 1.5 cm after collection of tumor for immunologic analyses)
- At least one prior treatment regimen but no more than 3 prior chemotherapy regimens; patients previously treated with monoclonal antibodies or radiotherapy to a single site will be eligible; these therapies will be considered prior treatment regimens but will not be considered as prior chemotherapy; tumor vaccines will not be counted as prior therapies, as all such agents are investigational
- Absolute neutrophil count (ANC) \>= 1000/uL
- Platelets (PLT) \>= 75,000/uL
- Total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =\< 3 x upper limit or normal (ULN)
- Creatinine =\< 1.5 x ULN
- Hemoglobin \>= 8 g/dL
- Ability to provide informed consent
- Willingness to return to the Mayo Clinic Rochester or the University of California, Los Angeles for follow up
- Life expectancy \>= 24 weeks
- Willingness to provide all biologic specimens as required by the protocol
You may not qualify if:
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, 3, or 4
- Any uncontrolled infection, hepatitis C virus (HCV)+ (unless HCV ribonucleic acid \[RNA\]-negative by polymerase chain reaction \[PCR\]) or hepatitis B surface antigen (HBsAg)+, or human immunodeficiency virus (HIV) positive patients or patients with known immune deficiency states
- Previous MDX-010 therapy regardless of interval since last treatment
- Prior treatment with fludarabine or 2-chlorodeoxyadenosine =\< 12 months prior to registration
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- New York Heart Association classification III or IV or a history of angina pectoris requiring active treatment
- Clinical evidence of central nervous system involvement by lymphoma
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.)
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
- Diagnosis of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL)
- Any requirement for concurrent steroid therapy, including use of inhaled steroids for asthma
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Stephen Ansell
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Ansell
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2004
First Posted
August 5, 2004
Study Start
June 1, 2004
Primary Completion
July 1, 2008
Study Completion
October 1, 2009
Last Updated
May 30, 2014
Results First Posted
October 19, 2012
Record last verified: 2012-12