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Anti-tumor antibiotic
Nivolumab + Chemotherapy for Peripheral T-Cell Lymphoma
Phase 1 & 2
Waitlist Available
Led By Brad Haverkos, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0 - 2
Histologically confirmed new diagnosis of Stage II, III or IV Peripheral T-cell Non-Hodgkin's lymphoma not otherwise specified (NOS), Anaplastic large cell lymphoma (ALK-negative) (ALK-positive if IPI 3, 4, or 5), Angioimmunoblastic T-cell lymphoma, Enteropathy associated T-cell lymphoma (MEITL and EATL), Hepatosplenic T-cell lymphoma, y/8 T-cell lymphoma, Subcutaneous panniculitis-like T-cell lymphoma, and Nodal T-cell lymphomas with T-follicular helper phenotype
Must not have
History of non-infectious pneumonitis requiring immuno-suppressive therapy
Patients with a diagnosis of other PTCL histologies other than those specified in the inclusion criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment for peripheral T cell lymphoma using nivolumab and standard chemotherapy. Nivolumab helps the immune system fight cancer, and chemotherapy kills cancer cells. Nivolumab has shown benefits in various cancers by improving survival rates and is often used in combination with other treatments.
Who is the study for?
Adults over 18 with certain types of Peripheral T-cell Non-Hodgkin's lymphoma, stages II-IV, who can sign consent and follow the study plan. They should have adequate organ function and no prior significant treatments except possibly one chemotherapy cycle or radiation. Pregnant women, those with other recent cancers or autoimmune diseases needing treatment, active hepatitis B/C or HIV are excluded.
What is being tested?
The trial is testing Nivolumab combined with standard chemotherapy drugs (Prednisolone, Cyclophosphamide, Etoposide, Oncovin [Vincristine], Hydroxydaunorubicin) to see if it's effective as a first-line treatment for peripheral T cell lymphomas.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs (pneumonitis), liver issues from elevated enzymes/bilirubin levels in blood tests; fatigue; increased risk of infections due to lowered white blood cells; nausea; hair loss from chemo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than 50% of my waking hours.
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I have been diagnosed with a specific type of advanced T-cell lymphoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had lung inflammation treated with immune-suppressing drugs.
Select...
My cancer type is not listed in the trial's specified types.
Select...
I have previously received PD-1 or PD-L1 antibody treatment.
Select...
I am allergic or cannot take certain medications needed for the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days after last dose of nivolumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days after last dose of nivolumab
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy: Complete Response Rate
Secondary study objectives
Efficacy: Event Free Survival
Efficacy: Overall Response Rate
Efficacy: Progression Free Survival Rate
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab and EPOCHExperimental Treatment6 Interventions
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Etoposide
2010
Completed Phase 3
~2960
Oncovin
2005
Completed Phase 2
~220
Prednisolone
2005
Completed Phase 4
~3570
Cyclophosphamide
2010
Completed Phase 4
~2310
Hydroxydaunorubicin
2005
Completed Phase 2
~180
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral T-Cell Lymphoma (PTCL) treatments often include immunotherapy and chemotherapy. Nivolumab, a PD-1 inhibitor, works by blocking the PD-1 protein on T cells, preventing cancer cells from evading the immune response, thus enhancing the body's ability to fight the cancer.
This is crucial for PTCL patients as it offers a targeted approach that can be more effective and potentially less toxic than traditional chemotherapy. Other treatments may include combination chemotherapy, which aims to kill rapidly dividing cancer cells but can have significant side effects.
The emphasis on immunotherapy, like Nivolumab, represents a shift towards treatments that harness the patient's immune system to combat the lymphoma more effectively.
Cancer-targeted photoimmunotherapy induces antitumor immunity and can be augmented by anti-PD-1 therapy for durable anticancer responses in an immunologically active murine tumor model.Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Ipilimumab pharmacotherapy in patients with metastatic melanoma.
Cancer-targeted photoimmunotherapy induces antitumor immunity and can be augmented by anti-PD-1 therapy for durable anticancer responses in an immunologically active murine tumor model.Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Ipilimumab pharmacotherapy in patients with metastatic melanoma.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,281 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,570 Total Patients Enrolled
Brad Haverkos, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on immune-suppressing drugs recently, except for inhaled/topical steroids or prednisone for adrenal issues without auto-immune disease.I have an auto-immune condition but only take medication like thyroid or insulin replacements.I have had lung inflammation treated with immune-suppressing drugs.I have had another cancer treated to relieve symptoms within the last 2 years, or I have had certain types of cancer that are considered low risk.My cancer type is not listed in the trial's specified types.I can take care of myself and am up and about more than 50% of my waking hours.I've had only one round of chemotherapy or radiation for my current condition.I do not have active hepatitis B or C, or HIV.I have previously received PD-1 or PD-L1 antibody treatment.I have not received a live virus vaccine in the last 30 days.I have been diagnosed with a specific type of advanced T-cell lymphoma.My cancer started in the brain's lymphatic cells, but it's okay if it spread there from elsewhere.I am allergic or cannot take certain medications needed for the trial.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab and EPOCH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.