Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Aga… (NCT01535885) | Clinical Trial Compass
CompletedPhase 1
Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV
United States25 participantsStarted 2012-02
Plain-language summary
This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient age \< 22 years.
* Both genders and all races are eligible.
* The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
* Must be willing to sign a written informed consent.
* Patient Organ Status at the time of enrollment (pre-transplant)
* Lansky or Karnofsky score \> 50
* Echocardiogram shortening fraction \> 27%
* Renal function: serum creatinine \< 2 x normal for age
* DLCO \> 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients.
* Hepatic: AST, ALT \< 5x upper limit of normal; bilirubin \< 2.0 mg/dl
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom.
* Patients must be between 28 and 100 days post T-cell depleted allogeneic HPCT
* Patients must meet the following criteria (within 72 hours of CTL infusion):
* Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days.
* No oxygen requirement with oxygen saturations \> 90%.
* AST, ALT \< 5x upper limit of normal for age; bilirubin \< 2 mg/dl.
* Hemoglobin \> 8 gm/dl prior to infusion. (May be transfusion dependent).
* Renal function: serum creatinine \< 2 x normal for…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess toxicity by SAEs scored according to the adaptive CTCAE version 5