Is NCT05711667 recruiting in Aurora, CO?

Yes, NCT05711667 is currently recruiting participants at its Aurora, CO location. This hematopoietic and lymphoid cell neoplasm clinical trial is actively enrolling qualified participants.

Is participation in this Aurora 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.

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial in Aurora, CO

Q: How do I join the hematopoietic and lymphoid cell neoplasm clinical trial in Aurora?

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

About This Hematopoietic and Lymphoid Cell Neoplasm Study in Aurora

This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. "Prophylaxis" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.

Sponsor: Children's Oncology Group

Who Can Participate

Inclusion Criteria

\>= 2 years and \< 18 years at the time of enrollment

Weight must be \>= 6 kg at the time of enrollment

Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant)

Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive)

Note: If a patient has hypogammaglobulinemia but has previously been documented as CMV sero-positive, that is acceptable for study inclusion. For all patients already confirmed to be CMV IgG seropositive, repeat testing is not required within 7 days prior to enrollment. However, the laboratory data determining eligibility must be available in the patient's medical/research record for verification

Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period

Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant preparative regimen

Patient must have a performance status corresponding to Lansky/Karnofsky scores \> 50

Note: Use Lansky for patients =\< 16 years of age and Karnofsky for patients \> 16 years of age. For further reference, see performance status scales scoring under the standard sections for protocols among protocol reference materials provided on the Children's Oncology Group (COG) member website: https://members.childrensoncologygroup.org/prot/reference\_materials.asp

Estimated glomerular filtration rate \> 10 mL/min/1.73 m\^2 and not receiving dialysis

Direct bilirubin =\< 2 mg/dL and serum glutamate-pyruvate transaminase (SPGT) (alanine transaminase \[ALT\]) =\<10 x upper limit of normal (ULN) for age

Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L

Exclusion Criteria

Expected inability to tolerate oral formulation of letermovir

Hypersensitivity to letermovir or any component of the formulation

History of CMV end organ disease within 6 months (180 days) prior to enrollment

Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease

Receipt of prior allogeneic HCT within one year of study enrollment

Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including:

High dose acyclovir (defined as doses \>= 1500 mg/m\^2 IV or \>= 3200 mg oral (patients \>= 40 kg) or \>= 2400 mg/m\^2 (patients \< 40 kg) per day)

High dose valacyclovir (defined as doses \>= 3000 mg/day in patients \> 20 kg)

Ganciclovir

Valganciclovir

CMV-directed cytotoxic T lymphocytes

Planned receipt of the following contraindicated medications during the study treatment period; contraindicated medications must be discontinued at least 14 days prior to Day +1

Contraindicated medications for all patients:

Ergot alkaloids

Contraindicated medications for patients planned to receive cyclosporine:

Pitavastatin

Simvastatin

Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted in certain animal reproduction studies with letermovir. A pregnancy test is required for female patients of childbearing potential

Lactating females who plan to breastfeed their infants

Sexually active female patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their letermovir treatment and through at least 4 weeks after the last dose of letermovir.

Note: No contraception measures are needed specifically during letermovir treatment for male trial participants who have pregnant or non-pregnant female partner(s) of reproductive potential. Contraception measures may be required for other aspects of the HCT procedure.

All patients and/or their parents or legal guardians must sign a written informed consent

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

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 Aurora?

Yes, this clinical trial (NCT05711667) has an active research site in Aurora, CO 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.

Hematopoietic and Lymphoid Cell Neoplasm Treatment Options in Aurora, CO

If you're searching for hematopoietic and lymphoid cell neoplasm treatment options in Aurora, CO, this clinical trial (NCT05711667) 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 Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hematopoietic and lymphoid cell neoplasm 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 hematopoietic and lymphoid cell neoplasm clinical trials near you to find additional studies recruiting in your area.

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial in Aurora, CO

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