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Antibody-drug conjugate
Belantamab Mafodotin for Lymphoma
Phase 2
Recruiting
Research Sponsored by Jacob Soumerai, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter [LDi] to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥15 mm in LDi for nodal disease or ≥10 mm in LDi for extranodal lesions.
No interference from prior or concurrent malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening; after 2 months; after 4 months, after 6 months; then every 6 months on therapy up 2 years
Awards & highlights
Study Summary
This trial is studying how well belantamab mafodotin works in treating patients with relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma.
Who is the study for?
Adults with relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma who have measurable disease and have previously undergone systemic lymphoma therapy. Participants must be in relatively good health (ECOG ≤2), not pregnant, using contraception, able to consent, and without serious concurrent illnesses or recent treatments that could interfere.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of belantamab mafodotin, an antibody-drug conjugate designed to target and kill lymphoma cells. It's for patients whose cancer has returned after treatment or didn't respond to previous therapies.See study design
What are the potential side effects?
Potential side effects of belantamab mafodotin include reactions at the infusion site, changes in vision due to corneal issues, low blood cell counts which can increase infection risk or cause fatigue/bleeding problems, liver function changes, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured and is at least 10mm or 15mm big depending on its location.
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I don't have any other cancer affecting my current treatment.
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My blood counts meet the required levels for treatment.
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My condition is a specific type of lymphoma that has returned or did not respond to treatment.
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I have previously undergone treatment for lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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I have received treatment for lymphoma before.
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I am 18 years old or older.
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My liver and kidney functions are within normal ranges.
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My heart condition allows me to perform daily activities with slight limitations.
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My lymphoma has returned or didn't respond to treatment.
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I am 18 years old or older.
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I can take care of myself but might not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening; after 2 months; after 4 months, after 6 months; then every 6 months on therapy up 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening; after 2 months; after 4 months, after 6 months; then every 6 months on therapy up 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Complete Response Rate
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Overall Survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: (BELANTAMAB MAFODOTINExperimental Treatment1 Intervention
Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle.
Treatment is intended to be administered on an outpatient basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
FDA approved
Find a Location
Who is running the clinical trial?
Jacob Soumerai, MDLead Sponsor
1 Previous Clinical Trials
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,791 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that can be measured and is at least 10mm or 15mm big depending on its location.I don't have any other cancer affecting my current treatment.Your platelet count must be at least 50,000 per microliter.I have a mild eye surface condition.Your blood must have a minimum level of hemoglobin of 8.0 g/dL.I have no major side effects from previous cancer treatments.My blood counts meet the required levels for treatment.I do not have any uncontrolled illnesses or active infections.I have not had plasmapheresis in the last week.My condition is a specific type of lymphoma that has returned or did not respond to treatment.I have previously undergone treatment for lymphoma.I can take care of myself but might not be able to do heavy physical work.Your bilirubin levels must be within the normal range or slightly higher but still safe for the study.I have received treatment for lymphoma before.I am currently experiencing bleeding from an internal organ or mucosa.Your liver enzyme levels (AST/SGOT and ALT/SGPT) are not too high, and are within the normal range.I am 18 years old or older.My lymphoma has spread to my brain or spinal cord.My liver and kidney functions are within normal ranges.My liver condition is stable.I haven't taken any new cancer drugs or approved treatments for my lymphoma in the last 14 days.I have not had major surgery in the last 4 weeks.My HIV infection is not under control.My heart condition allows me to perform daily activities with slight limitations.You have a mental health condition or social situation that makes it hard for you to follow the study requirements.You are currently participating in another study testing a new medication.My lymphoma has returned or didn't respond to treatment.I haven't had monoclonal antibody treatment in the last 30 days.You are pregnant or currently breastfeeding.My high blood pressure is not under control.You wear contact lenses.I am at risk for heart disease.You have enough infection-fighting white blood cells, with a count of at least 1,000 per microliter.I am 18 years old or older.I can take care of myself but might not be able to do active work.I haven't had any other cancers besides the one being studied in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: (BELANTAMAB MAFODOTIN
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
In how many distinct places is this particular clinical trial being conducted?
"This study is being conducted at 4 hospitals, which are situated in New york, Boston, Houston and 4 other cities. If you want to take part in this trial it would be best if chose a location near to you, so as to limit travel required."
Answered by AI
Are there any similar drugs to Belantamab Mafodotin that have undergone clinical trials?
"Weill Cornell Medicine / NewYork Presbyterian Hospital was the first to study Belantamab Mafodotin in 2015. There have been 2 completed studies and 33 active trials since then, with a high concentration of these studies taking place in New york City."
Answered by AI
Has this clinical trial been done before?
"Karyopharm Therapeutics Inc. first sponsored a clinical trial for Belantamab Mafodotin in 2015, with 518 participants. Since then, there have been 33 additional trials involving this medication taking place in 221 cities and 34 countries."
Answered by AI
Are there any vacancies in this research project for new participants?
"That is correct. The information available on clinicaltrials.gov points to this study being actively recruiting patients right now. This trial was first posted on July 1st, 2021 and updated September 20th, 2021. They are looking for 25 people to participate at 4 different locations."
Answered by AI
What is the Belantamab Mafodotin success rate according to the FDA?
"While Phase 2 trials are not as reliable in terms of efficacy, the data collected thus far suggests that Belantamab Mafodotin is safe."
Answered by AI
What health conditions does Belantamab Mafodotin usually treat?
"Belantamab Mafodotin is an immunomodulatory medication that can be used to treat patients with a previous proteasome inhibitor treatment, relapsed or refractory multiple myeloma."
Answered by AI
Who else is applying?
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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