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New treatment option for Hodgkin's Disease
Official title Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
ClinicalTrials.gov ID: NCT01555892
What this study is testing
What is EBV-specific T cells: A?
EBV-specific T cells: A is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hodgkin's disease.
Also referred to as LMP, BARF1 and EBNA1 specific CTLs.
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
- Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these diseases. Some of these patients show signs of virus that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono" or the "kissing disease") before or at the time of their diagnosis.
- Phase 1: an early, usually small safety study
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 at this time)
- Weighs at least 12kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. at time of Infusion
You likely can't join if
- at Time of Procurement 1\. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time) Exclusion Criteria at Time of Infusion
- Pregnant or lactating
- Severe intercurrent infection.
- Current use of systemic corticosteroids \> 0.5 mg/kg/day
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 or Severe Chronic Active EBV...
- EBV positive tumor (can be pending at this time)
- Weighs at least 12kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. at time of Infusion
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)\...
- EBV positive tumor
- Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value).
- Patients with a creatinine less than or equal to 2x upper limit of normal for age
- Pulse oximetry of \> 90% on room air
- Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. PD1/PDL inhibitors will be allowed if medically indicated.
- Patients with a Karnofsky/Lansky score of greater than or equal to 50
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded.
- Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given copy of informed consent.
- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
- Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant.
- at Time of Procurement 1\. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time) Exclusion Criteria at Time of Infusion
- Pregnant or lactating
- Severe intercurrent infection.
- Current use of systemic corticosteroids \> 0.5 mg/kg/day
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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.