Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Allogeneic Hematopoietic Stem Cell Transplantation Recipient Clinical Trial in Columbus, OH

Q: Is NCT03665675 recruiting in Columbus, OH?

Yes, NCT03665675 is currently recruiting participants at its Columbus, OH location. This allogeneic hematopoietic stem cell transplantation recipient clinical trial is actively enrolling qualified participants.

Q: How do I join the allogeneic hematopoietic stem cell transplantation recipient clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Allogeneic Hematopoietic Stem Cell Transplantation Recipient Study in Columbus

This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.

Sponsor: Sumithira Vasu

Who Can Participate

Inclusion Criteria

Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.

• Cohort A (CMV): Must have documented CMV disease or reactivation, as by:

Viremia as detected by quantitative polymerase chain reaction (PCR) (\> 500 IU/ml) in the peripheral blood requiring treatment OR

High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR

Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury • Cohort B (AdV): Must have documented AdV infection or reactivation, as by:

Symptomatic subject with any detectable viral load in blood, OR

Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and/or other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood viral load, OR

New, persistent, and/or worsening AdV-related symptoms, signs, and/or markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR

Asymptomatic with a viral load \> 1000 copies/ml in peripheral blood, OR

Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury

Karnofsky (age \> 16 years) or Lansky performance score \> 70 (age \< 16)

Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation

Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen

Written informed consent and/or signed assent line from patient, parent or guardian

Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards

Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG)

Cohort B: AdV seropositive, defined as detection of serum AdV IgG

Age 18 or over

Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for donation per institutional standards, the donor will be eligible for the protocol

Exclusion Criteria

Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.

Receipt of \> 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg/kg/day of prednisone or steroid equivalent.

Evidence of uncontrolled infection as follows:

Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.

Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.

Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

Receipt of donor lymphocyte infusion (DLI) within 28 days.

Patients with active acute graft versus host disease (GvHD) grades II-IV requiring \> 0.5 mg/kg/day of prednisone or steroid equivalent or T-cell depleting immunosuppression.

Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above.

Active and uncontrolled relapse of malignancy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT03665675) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Allogeneic Hematopoietic Stem Cell Transplantation Recipient Treatment Options in Columbus, OH

If you're searching for allogeneic hematopoietic stem cell transplantation recipient treatment options in Columbus, OH, this clinical trial (NCT03665675) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this early phase 1 clinical trial. You'll receive care from experienced allogeneic hematopoietic stem cell transplantation recipient specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all allogeneic hematopoietic stem cell transplantation recipient clinical trials near you to find additional studies recruiting in your area.

Allogeneic Hematopoietic Stem Cell Transplantation Recipient Clinical Trial in Columbus, OH

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