HLA-matched VSTs for Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Children's Hospital, Houston, TX
Infections+4 More
HLA-matched VSTs - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.

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Eligible Conditions

  • Infections
  • Viral Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether HLA-matched VSTs will improve 2 primary outcomes in patients with Infections. Measurement will happen over the course of 6 weeks.

6 weeks
Dose Limiting toxicity: (DLT) rate by CTCAE v5
Overall Response Rate: (The viral load of the virus (or viruses) by viral PRC (replication-competent retrovirus) within 42 days)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

HLA-matched VSTs
1 of 1
Experimental Treatment

This trial requires 47 total participants across 1 different treatment group

This trial involves a single treatment. HLA-matched VSTs is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

HLA-matched VSTs
Biological
Partially HLA-matched VSTs will be thawed and given by intravenous injection. Patients will receive 2 x 107 partially HLA-matched VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused with agreement of the principal investigator, patient and/or guardian and the treatment team Additional doses may be from the same donor or a different donor based on available cell lines and patient/disease factors. Decision to switch to a different donor can be made by the principal investigator based on factors that include sequential treatment of different viral infections, concerns for immune escape of the targeted virus and/or availability of a better matched or otherwise superior VST line. Additional treatments will only be given following the agreement of the patient, treating physician, and investigator. This process can be repeated as needed.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 weeks for reporting.

Who is running the study

Principal Investigator
J. C.
Prof. John Craddock, Associate Professor
Baylor College of Medicine

Closest Location

Texas Children's Hospital - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Infections or one of the other 4 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If you are a female of childbearing potential, and you take a negative pregnancy test after reduced intensity conditioning, this means that you are not pregnant. show original
Patients must have received a prior allogeneic hematopoietic stem cell transplant using bone marrow, single/double cord blood or PBSC show original
is investigational There is currently no standard treatment for patients with multiple infections from Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus, and/or BK virus following treatment failure or patients who are unable to tolerate standard therapy show original
Hgb ≥ 7.0 gm/dl
People who have relapsed or continued to have reactivation or infection from Epstein-Barr virus, CMV, adenovirus, or BK virus, despite standard treatment, are eligible to enroll in this study. show original
Treatment of JC virus infection
Steroids less than or equal to 1.0 mg/kg/day methylprednisolone (or equivalent)
Any available VST must be partially HLA matched and verified in order to be used in a simulation. show original
Patient or parent/guardian capable of providing informed consent.

Patient Q&A Section

What causes infections?

"Infections are one of the most common causes of death among patients with hematologic cancers, and the cause of death can be directly related to the type of treatment given. There are many possible causes of infection, and in each patient with leukemia, an assessment by a hematologist or oncologist should be obtained if an infection is identified. An antibiotic prescription is recommended, and consideration should be given to instituting an infected blood-products protocol as a method of decreasing infections in patients receiving chemotherapy. The Infectious Diseases Society of America has published guidelines on prudent use of antibiotics and prudent use of blood products. These guidelines should be used in all patients with hematologic malignancies." - Anonymous Online Contributor

Unverified Answer

What are the signs of infections?

"The symptoms of an infection range widely and include fever, headache, muscle aches, and tiredness. The main symptoms for pneumonia and acute upper respiratory infections are fever, coughing, shortness of breath, and feeling unwell. Fever is a symptom of many infections and may be the first symptom to appear. Other features of infections may include a runny nose and an increased temperature. It may then take 6 to 10 days for the temperature to return to normal." - Anonymous Online Contributor

Unverified Answer

What are common treatments for infections?

"It is important to consider that the presence of serious illness, or pre-existing conditions will likely exacerbate the extent to which infection contributes to symptom intensity. Common treatments for infection are antibiotics, anti-neurons, or prophylactic antibiotics. Also, prophylactic antibiotics have been shown to be effective in some cases of infectious mononucleosis (IM)." - Anonymous Online Contributor

Unverified Answer

What is infections?

"Infections are diseases caused by the presence of pathogenic organisms in the body; more specifically, by specific diseases caused by pathogenic bacteria. The infectious agents are spread by the direct action of these pathogens on their host's bodily membranes or through inanimate material transfer. They are also caused by viruses, prion diseases, toxins, or any other pathogenic agents or agents of chemical origin such as medications. There are many different types of infections and they differ from each other depending on the type of organism involved. Understanding infections might enable doctors to prevent or treat a wide spectrum of infectious diseases in humans and other vertebrates - a process known as nosocomial infections." - Anonymous Online Contributor

Unverified Answer

How many people get infections a year in the United States?

"About 8.9 million people get infections the U.S. A year. The majority of cases are acquired in homes, workplaces and in public places. The most common infections include influenza, chicken pox, mononucleosis, and ear, nose and throat infections. Infections occur during childhood and are usually well-controlled with vaccines and antibiotics. Infection-associated deaths are declining and represent some of the few instances in which they may be prevented completely." - Anonymous Online Contributor

Unverified Answer

What does hla-matched vsts usually treat?

"The use of a hlamatched donor vst resulted in lower morbidity and mortality in both the heart and lung, compared with conventional vsts. In a recent study, findings support the inclusion of grafts from HLA-matched donors in transplantation programs." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for infections?

"In this large national sample of pediatric IBD patients, most patients, including adults, were already treated in clinical trials. IBD patients' willingness to use clinical trials for infections was much higher than in the general population." - Anonymous Online Contributor

Unverified Answer

Is hla-matched vsts typically used in combination with any other treatments?

"Compared with hla-matched vsts, mvsts were not associated with lower survival rates and no difference in treatment failures. Therefore, mvsts can be used in combination with other treatments. However, a meta-analysis of trials was not able to reveal whether this treatment approach improved survival. It is important to note that most MVA combinations are still investigational, so they are not yet well established as treatment regimens for SLE. Future studies should address the use of these treatments in SLE." - Anonymous Online Contributor

Unverified Answer

Is hla-matched vsts safe for people?

"Hla-matched donors/recipients have higher risk of transfemorally transmitted infections than B+ donors/recipients. HLA typing is recommended prior to the donation of HLA-matched blood and deferral from blood donation could be a solution to this problem, but prospective randomized proof of this solution is lacking." - Anonymous Online Contributor

Unverified Answer

How serious can infections be?

"To keep a good quality of life and be a productive member of society, we want to learn more about the effects of infections on our functioning." - Anonymous Online Contributor

Unverified Answer

What is the latest research for infections?

"In the past 5 years, more than 50 clinical trials examining treatments and/or vaccines for prevention of infections have been completed; however, there are many other conditions, including urinary-tract infections, sepsis, pneumonia, cellulitis, pelvic inflammatory disease, urinary, and lower-respiratory infections, and meningitis that have or might have been included in future clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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