Active cytomegalovirus (CMV) retinitis, or other active CMV-related organ dysfunction
EXCLUSION - PROCUREMENT: Clinically significant viral infection or uncontrolled viral reactivation of Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus (Adv), BK-virus, or human herpesvirus 6 (HHV-6)
Active viral infection requiring treatment with anti-viral medication (uncomplicated cytomegalovirus [CMV] viremia that is responding to antiviral medications is allowed)
Active or recent herpes simplex virus (HSV) infection or cytomegalovirus (CMV) based on symptoms with positive swab culture and/or positive Immunoglobulin M (IgM) screening, which would complicate the post-conditioning period
Active or recent herpes simplex virus (HSV) infection or cytomegalovirus (CMV) based on symptoms with positive swab culture and/or positive IgM screening
Patients with history of (h/o) pneumocystis pneumonia (PCP) or positive cytomegalovirus (CMV) viremia confirmed twice at least 1 day apart at screening
At time of protocol enrollment, the patient should be negative for cytomegalovirus (CMV) by antibody testing or by PCR; in case of disagreement between these 2 CMV tests, the tests will be repeated and department (Dept.) of Laboratory Medicine consulted
Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.
Any history or evidence of opportunistic infection within 6 months of screening including tuberculosis, severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible
DONOR: Any cord blood units without the full maternal testing and negative results for hepatitis A, B, C, HIV, and human T-lymphotropic virus (HTLV-1) viruses; any additional available virology results on the unit itself will be reviewed but are not mandated, complete or always available; cord blood units are presumed to be cytomegalovirus (CMV) negative regardless of serologic testing due to passive transmission of maternal CMV antibodies
Active acute infection, except for Herpes viruses (cytomegalovirus [CMV], Epstein Barr virus [EBV], herpes zoster virus [HZV], herpes simplex virus 1 [HSV 1]).
Evidence of end-organ Cytomegalovirus (CMV) infection
Cytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within the past 28 days
Cytomegalovirus colitis or enteritis as defined by cytomegalovirus (CMV) shell vial or culture positivity from endoscopic biopsy the discretion of the treating physician based upon PCR positivity, clinical presentation and histology
Active cytomegalovirus (CMV) retinitis or other active CMV-related organ dysfunction; patients with a history of treated CMV infection are not excluded
Active cytomegalovirus (CMV) retinitis or other active CMV-related organ dysfunction; patients with a history of treated CMV infection are not excluded
Evidence of severe retinopathy (e.g. cytomegalovirus [CMV] retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)
Evidence of severe retinopathy (e.g. cytomegalovirus [CMV] retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)
Positive cytomegalovirus (CMV) PCR test at baseline
Active Cytomegalovirus (CMV) retinitis or other CMV-related organ dysfunction.
MATCHED RELATED DONOR: Presence of any blood transmissible infectious disease that cannot be cleared prior to stem cell collection and poses an unacceptable risk for the recipient (excludes cytomegalovirus [CMV])
No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
Cytomegalovirus (CMV) PCR positive at baseline
Infections\r\n* ARM A: Without active uncontrolled bacterial, fungal or viral infection\r\n** Cytomegalovirus (CMV)- If CMV viremia is < 137 IU/ml, but patients are on therapy for CMV\r\n** Human herpes virus (HHV)-6 < 40,000 copies/ML and without active trend up\r\n* ARM B: No limitation
Active cytomegalovirus (CMV) disease at the time of enrollment
Persistent or recurrent cytomegalovirus infection or disease despite at least 7 days of standard therapy or failure of therapy as described below or if unable to tolerate standard therapy. Standard therapy is defined as antiviral therapy with ganciclovir or CMX001 (brincidofovir) as the agents of choice and foscarnet or cidofovir as second line agents. i.Cytomegalovirus infection: defined as the presence of CMV positivity as detected by Polymerase chain reaction (PCR) or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx. ii. Cytomegalovirus disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination. iii. Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy.
Active infection including cytomegalovirus
Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days
Patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus or EBV infection persistent to standard therapy (as defined below):\r\n* Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or single or double umbilical cord blood\r\n* CMV, adenovirus or EBV infection persistent despite standard therapy\r\n** For CMV infection:\r\n*** Patients with CMV disease defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR\r\n*** Failure of antiviral therapy defined as the continued presence of pp65 antigenemia (> 1+ cell/100,000 cells) or deoxyribonucleic acid (DNA)emia (as defined by reference lab performing polymerase chain reaction [PCR] assay but usually > 400 copies/ml) after at least 7 days of antiviral therapy OR\r\n*** Relapse after antiviral therapy defined as recurrence of either pp65 antigenemia or DNAemia after at least 2 weeks of antiviral therapy\r\n** For CMV infection, standard therapy is defined as 7 days therapy with ganciclovir, foscarnet or cidofovir for patients with disease or recurrence after 14 days therapy\r\n** For EBV infection:\r\n*** EBV infection is defined as biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR OR clinical or imaging findings consistent with EBV lymphoma and elevated EBV viral load in peripheral blood\r\n*** For EBV infection, standard therapy is defined as rituximab given at 375 mg/m^2 in patients for 1-4 doses with a CD20 positive (+) tumor\r\n*** Failure is defined as there was an increase of less than 50% response at sites of disease for EBV lymphoma OR there was a rise or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease\r\n** For adenovirus infection or disease:\r\n*** Adenovirus infection is defined as the presence of adenoviral positivity as detected by PCR, DAA or culture from ONE site such as stool or blood or urine or nasopharynx OR adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from two or more sites such as stool or blood or urine or nasopharynx\r\n*** Standard therapy is defined as 7 days therapy with cidofovir (if renal function permits this agent to be given)\r\n*** Failure is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay
Cytomegalovirus (CMV) viremia.
Active infection with cytomegalovirus (CMV) as defined as CMV viral load >= 10,000 copies per mL of whole blood; CMV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active CMV infection
Known uncontrolled cytomegalovirus (CMV) polymerase chain reaction (PCR) reactivation per institutional standards; once CMV has been treated and stable per institutional standards, patient may be enrolled; CMV PCR will be tested within two weeks prior to starting study drug