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Monoclonal Antibodies
NK Cell Therapy + Mogamulizumab for T-Cell Lymphoma/Leukemia
Phase 1
Recruiting
Led By John C Reneau, MD
Research Sponsored by John Reneau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at study entry
Patients with large cell transformation of cutaneous T cell lymphoma are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment to date of death due to any cause. in the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive, whichever comes first, assessed up to 2 years
Awards & highlights
Study Summary
This trial is to find out the benefits and side effects of immunotherapy with natural killer cells in combination with a cancer-fighting antibody for patients with skin T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back or does not respond to treatment.
Who is the study for?
Adults over 18 with relapsed or refractory cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma, who've had at least one prior systemic therapy. Participants must have adequate organ function and performance status, not be pregnant, and free from severe allergies to monoclonal antibodies or certain infections. Those with a history of other cancers may join if they've been disease-free for two years.Check my eligibility
What is being tested?
The trial is testing the combination of third-party natural killer cells and mogamulizumab to determine the best dose and assess potential benefits/side effects in treating specific lymphomas that are resistant to standard treatments. It's an early-phase study exploring how this immunotherapy can help control cancer growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs due to mogamulizumab, which is designed to target cancer cells but might affect normal cells too. Other common side effects could involve fatigue, digestive issues, blood disorders, increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My skin lymphoma has changed into a more aggressive form.
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I have ATLL, received chemotherapy, and my disease can currently be measured.
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My kidneys are functioning well, with a creatinine clearance rate of at least 50 ml/min.
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My skin lymphoma has returned or didn't respond after one treatment.
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My liver enzymes are within acceptable limits for someone with lymphoma affecting the liver.
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My condition relapsed after a stem cell transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study treatment to date of death due to any cause. in the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive, whichever comes first, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment to date of death due to any cause. in the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive, whichever comes first, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Analysis of cytokine levels
Natural Killer (NK)-cell numerical expansion in vivo
Overall response rate (ORR)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mogamulizumab, chemotherapy, NK cells)Experimental Treatment6 Interventions
Patients receive mogamulizumab IV over 60 minutes on day -7 and fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients receive NK cell infusion on day 0. Patients then receive mogamulizumab IV over 60 minutes on days 0, 7, 14, and 28, then every 2 weeks thereafter in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mogamulizumab
FDA approved
Natural Killer Cell
Not yet FDA approved
Cyclophosphamide
FDA approved
Fludarabine
FDA approved
Find a Location
Who is running the clinical trial?
John ReneauLead Sponsor
3 Previous Clinical Trials
75 Total Patients Enrolled
John C Reneau, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
25 Total Patients Enrolled
John C Reneau, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and willingly sign a consent form.My lymphoma has spread to my brain or spinal cord.I am experiencing moderate to severe symptoms from a transplant reaction.You have had serious allergic reactions to certain types of medications called humanized monoclonal antibodies.I am 18 years old or older.I am fully active or can carry out light work.I have had a solid organ transplant.My skin lymphoma has changed into a more aggressive form.I have stopped taking steroids at least 1 week before joining this study, but I can use topical steroids.I have ATLL, received chemotherapy, and my disease can currently be measured.My kidneys are functioning well, with a creatinine clearance rate of at least 50 ml/min.I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.I stopped all cancer treatments at least 1 week ago, or longer if needed, but may still be on low-dose steroids for skin issues.I've been cancer-free for 2 years, except for certain skin cancers, early prostate cancer, or specific treated cancers.I have active hepatitis B or C, or need to take precautions due to hepatitis B.I have had skin cancer, early-stage melanoma, or cervical cancer but am otherwise healthy.My skin lymphoma has returned or didn't respond after one treatment.I have not been treated with mogamulizumab, or I stopped it for reasons other than worsening or side effects.I am currently on medication to suppress my immune system.My liver enzymes are within acceptable limits for someone with lymphoma affecting the liver.I have not had major surgery in the last 6 weeks.Extracorporeal photopheresis is counted as a systemic therapy in this study.My condition relapsed after a stem cell transplant.I have heart problems that affect my daily activities.I have HIV with a CD4 count below 350.You have received experimental treatments in the two weeks before starting the trial.I have a significant history of liver disease.I have never had progressive multifocal leukoencephalopathy.I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mogamulizumab, chemotherapy, NK cells)
Awards:
This trial has 2 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What has Mogamulizumab been prescribed to alleviate?
"Mogamulizumab has been approved for multiple sclerosis therapy and may also be beneficial in treating leukemia, myelocytic, acute relapsed cases of mycosis fungoides/sezary syndrome, and retinoblastoma."
Answered by AI
Has Mogamulizumab been granted clearance by the FDA?
"Due to the small scope of data surrounding Mogamulizumab, our team at Power has assigned it a score of 1 on a scale from 1-3 based on its Phase 1 status."
Answered by AI
How many participants are receiving treatment through this research endeavor?
"Affirmative. The information listed on clinicaltrials.gov signals that this medical study is presently recruiting patients and volunteers. It was first posted on May 6th 2022, with the most recent update made in November 18th 2022. In total, 12 individuals are needed to be recruited at 1 trial site."
Answered by AI
Are there any additional research initiatives related to Mogamulizumab?
"At present, Mogamulizumab is the subject of 917 ongoing trials with a total of 161 in their final stage. An abundance of these studies are taking place in Philadelphia, Pennsylvania; but this molecule's research spans across 28,522 locations worldwide."
Answered by AI
Are investigators presently enrolling new participants in this experiment?
"Affirmative, the details posted on clinicaltrials.gov demonstrate that this trial is actively recruiting participants. It was initially announced on May 6th 2022 and its parameters were recently adjusted on November 18th 2022. 12 individuals need to be enrolled from one medical centre."
Answered by AI
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