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New treatment option for EBV-Related Hodgkin Lymphoma
Official title EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
ClinicalTrials.gov ID: NCT04664179
What this study is testing
What is Dose Level 1A: 2 x 10^7 cells/m2?
Dose Level 1A: 2 x 10^7 cells/m2 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ebv-related hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- AT TIME OF PROCUREMENT
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV...
- EBV positive tumor (can be pending)
- Weighs at least 10 kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
You likely can't join if
- AT TIME OF PROCUREMENT 1\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
- EXCLUSION CRITERIA AT TIME OF INFUSION
- Pregnant or breastfeeding
- Active and uncontrolled bacterial, viral or fungal infection
- Current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day)
- Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
See the full eligibility criteria
- AT TIME OF PROCUREMENT
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T/NK-lymphoproliferative disease who may subsequently be...
- EBV positive tumor (can be pending)
- Weighs at least 10 kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
- AT TIME OF INFUSION 1) Any patient regardless of age or sex, with diagnosis of either
- EBV positive Hodgkin's lymphoma
- EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
- EBV (associated)-T/NK-lymphoproliferative disease AND either A) In first or subsequent relapse or with persistent active disease despite therapy; OR B) With active disease if immunosuppressive chemotherapy is...
- AT TIME OF PROCUREMENT 1\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
- EXCLUSION CRITERIA AT TIME OF INFUSION
- Pregnant or breastfeeding
- Active and uncontrolled bacterial, viral or fungal infection
- Current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day)
- Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.