Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation
22 de julio de 2026 actualizado por: LucasBio
A Single-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation in Children, Adolescents, and Adults
The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are:
- Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis?
- Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients.
Participants will:
- Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10^7/m^2; high dose: 2x10^7/m^2).
- Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose.
- Visit the clinic every week for follow-up for 6 months after the first dose.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
42
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nayoun Kim, Ph.D.
- Número de teléfono: +82 1040222340
- Correo electrónico: nkim@lucasbio.com
Ubicaciones de estudio
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Daegu, Corea del Sur, 41404
- Kyungpook National University Chilgok Hospital
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Investigador principal:
- Joonho Moon, MD-PhD
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Goyang-si, Corea del Sur, 10408
- National Cancer Center Korea
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Investigador principal:
- Hyeon Jin Park, MD-PhD
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Hwasun, Corea del Sur, 58128
- Chonnam National University Hwasun Hospital
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Investigador principal:
- Hoon Kook, MD-PhD
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Seoul, Corea del Sur, 07804
- Ewha Womans University Seoul Hospital
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Investigador principal:
- Eun Sun Yoo, MD-PhD
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Ulsan, Corea del Sur, 44033
- Ulsan University Hospital
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Investigador principal:
- Jae-Cheol Jo, MD-PhD
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Seoul
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Seoul, Seoul, Corea del Sur, 03080
- Seoul National University Hospital
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Investigador principal:
- Hyoung Jin Kang, MD-PhD
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Seoul, Seoul, Corea del Sur, 05505
- Asan Medical Center
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Investigador principal:
- Ho-joon Im, MD-PhD
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Seoul, Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Investigador principal:
- Yae-Jean Kim, MD-PhD
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Seoul, Seoul, Corea del Sur, 03722
- Severance Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients who have undergone allogeneic hematopoietic stem cell transplantation, including pediatric and adolescent patients as well as adults who were 12 years of age or older at the time of transplantation. However, only adults aged 19 years or older are eligible for enrollment in Phase 1.
Patients diagnosed with BK virus-associated hemorrhagic cystitis who meet all three of the following criteria.
- Clinical symptoms and signs of cystitis, such as lower abdominal pain and dysuria
- Hematuria of grade 2 or higher according to the Bedi criteria
- Detection of BKV >7log10 copies/mL in urine
- Subjects confirmed by the investigator to be unresponsive to treatment despite at least 7 days of standard inpatient therapy.
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5 × 10³/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients for whom at least 21 days (D+21) have elapsed since allogeneic hematopoietic stem cell transplantation as of the screening date.
- Patients who are able to reduce their steroid dosage to 0.5 mg/kg/day of prednisolone (or an equivalent dose) or less.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:
- Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)
- Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and/or a uterus)
- Individuals who have agreed to strict abstinence during the clinical trial period [For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence]
If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:
- Hormonal contraceptives (implant, patch, oral)
- Intrauterine devices
- Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)
- Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.
- Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Exclusion Criteria:
- Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.
- Patients with hemorrhagic cystitis caused by adenovirus (excluded via urine PCR)
- Patients with bacterial growth in urine culture (excluded via bacterial culture)
Individuals who meet any of the following criteria at the time of screening:
Uncontrolled hypertension
- Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.
Uncontrolled diabetes: Severe diabetes is defined as follows.
- Severe hyperglycemia with HbA1C ≥ 10.0%
- Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.
- Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose <54 mg/dL) accompanied by seizures and loss of consciousness.
- Human Immunodeficiency Virus (HIV) infection
- Hepatitis B Virus (HBV) infection. However, individuals who are HBsAg-negative and Anti-HBcAb-positive are not subject to this exclusion criterion.
- Hepatitis C Virus (HCV) infection
- Tuberculosis
- Syphilis
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)]
Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria.
- Bacterial infection Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.
- Fungal infection The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.
- Active acute graft-versus-host disease (GvHD) of grade 3 or higher.
- Patients requiring urgent anticancer therapy due to rapid tumor progression.
- Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.
- Patients requiring vasopressors.
- Patients who have previously shown hypersensitivity to T-cell therapy.
- Patients with a history of autoimmune disease.
- Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.
- Patients who have received another investigational drug within 24 weeks prior to administration of the investigational drug.
- Patients with a life expectancy of less than 24 hours at the time of the screening visit.
- Patients deemed ineligible for participation in this clinical trial by the investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Grupo placebo
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Standard-of-care therapy for BK virus-associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation will be administered according to the participant's clinical status by the principal investigator.
Participants in the placebo group will not receive LB-DTK-BKV during the clinical trial.
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Experimental: Grupo experimental
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LB-DTK-BKV derived from a designated donor determined based on the type of allogeneic hematopoietic stem cell transplant the subject is undergoing.
A pale yellow cell suspension filled in a colorless, transparent freeze-dried vial that is stored frozen until thawed into liquid before administration.
Study participants will receive a single intravenous infusion of the assigned cell dose (low dose: 1x10^7/m^2;high dose: 2x10^7/m^2) on Visit 2 and 14 days after the initial dose.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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BK virus viral load
Periodo de tiempo: From enrollment through 24 weeks after treatment initiation.
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BK viral load testing is performed using RT-PCR on urine samples.
Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
(That is, measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after treatment initiation.)
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From enrollment through 24 weeks after treatment initiation.
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Immunogenicity Testing
Periodo de tiempo: From enrollment through 24 weeks after treatment initiation.
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Immunogenicity testing using the IFN-γ ELISpot assay is performed weekly for the first 4 weeks following administration of the investigational drug.
Thereafter, to evaluate the persistence and reconstitution of the immune response, measurements are taken twice at 2-week intervals, once at 4-week intervals, and once at 12-week intervals.
(i.e., measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after dosing)
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From enrollment through 24 weeks after treatment initiation.
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Adverse Events
Periodo de tiempo: From enrollment through 24 weeks after treatment initiation.
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The investigator must confirm the occurrence of adverse events through medical examinations, including interviews and medical history reviews, during regular visits throughout the clinical trial period.
Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit (Visit 2); however, from the baseline visit (Visit 2) until the discharge date, adverse events shall be assessed daily, and after the discharge date, assessments shall be conducted according to the procedures for each visit; diseases or symptoms that occurred prior to the first administration of the investigational drug shall be collected as part of the medical history.
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From enrollment through 24 weeks after treatment initiation.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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BK virus viral load
Periodo de tiempo: From enrollment through 24 weeks after treatment initiation.
|
BK viral load testing is performed using RT-PCR on blood samples.
Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
(That is, measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after treatment initiation.)
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From enrollment through 24 weeks after treatment initiation.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Hyoung Jin Kang, MD-PhD, Department of Pediatric Hematology-Oncology, Seoul National University Hospital
- Investigador principal: Ho-joon Im, MD-PhD, Department of Pediatric Hematology & Oncology, Asan Medical Center
- Investigador principal: Hyeon Jin Park, MD-PhD, National Cancer Center, Korea
- Investigador principal: Seung Min Hahn, MD-PhD, Department of Pediatric Hematology & Oncology, Severance Hospital
- Investigador principal: Hoon Kook, MD-PhD, Department of Pediatric Hematology & Oncology, Chonnam National University Hwasun Hospital
- Investigador principal: Jae-Cheol Jo, MD-PhD, Department of Hematology, Ulsan University Hospital
- Investigador principal: Eun Sun Yoo, MD-PhD, Department of Pediatric Hematology Oncology, Ewha Womans University Seoul Hospital
- Investigador principal: Joonho Moon, MD-PhD, Department of Hematology-Oncology, Kyungpook National University Chilgok Hospital
- Investigador principal: Yae-Jean Kim, MD-PhD, Department of Pediatrics, Samsung Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
- Berger M, Lanino E, Cesaro S, Zecca M, Vassallo E, Faraci M, De Bortoli M, Barat V, Prete A, Fagioli F. Feasibility and Outcome of Haploidentical Hematopoietic Stem Cell Transplantation with Post-Transplant High-Dose Cyclophosphamide for Children and Adolescents with Hematologic Malignancies: An AIEOP-GITMO Retrospective Multicenter Study. Biol Blood Marrow Transplant. 2016 May;22(5):902-9. doi: 10.1016/j.bbmt.2016.02.002. Epub 2016 Feb 6.
- Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
- Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.
- Ciurea SO, Zhang MJ, Bacigalupo AA, Bashey A, Appelbaum FR, Aljitawi OS, Armand P, Antin JH, Chen J, Devine SM, Fowler DH, Luznik L, Nakamura R, O'Donnell PV, Perales MA, Pingali SR, Porter DL, Riches MR, Ringden OT, Rocha V, Vij R, Weisdorf DJ, Champlin RE, Horowitz MM, Fuchs EJ, Eapen M. Haploidentical transplant with posttransplant cyclophosphamide vs matched unrelated donor transplant for acute myeloid leukemia. Blood. 2015 Aug 20;126(8):1033-40. doi: 10.1182/blood-2015-04-639831. Epub 2015 Jun 30.
- Hunger SP, Mullighan CG. Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2015 Oct 15;373(16):1541-52. doi: 10.1056/NEJMra1400972. No abstract available.
- Jahangiri, V., et al., Post-Transplantation Cyclophosphamide (PTCY) Is Associated with Increased Risk of BK Virus-Associated Hemorrhagic Cystitis (BKHC) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HSCT). Biology of Blood and Marrow Transplantation, 2019.25 (3): p. S359-S360.
- Cho SG, Kim N, Sohn HJ, Lee SK, Oh ST, Lee HJ, Cho HI, Yim HW, Jung SE, Park G, Oh JH, Choi BO, Kim SW, Kim SW, Chung NG, Lee JW, Hong YS, Kim TG. Long-term Outcome of Extranodal NK/T Cell Lymphoma Patients Treated With Postremission Therapy Using EBV LMP1 and LMP2a-specific CTLs. Mol Ther. 2015 Aug;23(8):1401-1409. doi: 10.1038/mt.2015.91. Epub 2015 May 28.
- Simmons HZ, Bazzell AF, Dains JE. Adverse Effects of Virus-Specific T-Cell Therapy: An Integrative Review. J Adv Pract Oncol. 2019 Mar;10(2):120-131. Epub 2019 Mar 1.
- Cruz CR, Hanley PJ, Liu H, Torrano V, Lin YF, Arce JA, Gottschalk S, Savoldo B, Dotti G, Louis CU, Leen AM, Gee AP, Rooney CM, Brenner MK, Bollard CM, Heslop HE. Adverse events following infusion of T cells for adoptive immunotherapy: a 10-year experience. Cytotherapy. 2010 Oct;12(6):743-9. doi: 10.3109/14653241003709686.
- Green A, Rubinstein JD, Grimley M, Pfeiffer T. Virus-Specific T Cells for the Treatment of Systemic Infections Following Allogeneic Hematopoietic Cell and Solid Organ Transplantation. J Pediatric Infect Dis Soc. 2024 Feb 28;13(Supplement_1):S49-S57. doi: 10.1093/jpids/piad077.
- Martits-Chalangari K, Spak CW, Askar M, Killian A, Fisher TL, Atillasoy E, Marshall WL, McNeel D, Miller MD, Mathai SK, Gottlieb RL. ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient: Case report. Am J Transplant. 2022 Apr;22(4):1261-1265. doi: 10.1111/ajt.16927. Epub 2021 Dec 27.
- Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.
- Dadwal SS, Bansal R, Schuster MW, Yared JA, Myers GD, Matzko M, Adnan S, McNeel D, Ma J, Gilmore SA, Vasileiou S, Leen AM, Hill JA, Young JH. Final outcomes from a phase 2 trial of posoleucel in allogeneic hematopoietic cell transplant recipients. Blood Adv. 2024 Sep 10;8(17):4740-4750. doi: 10.1182/bloodadvances.2023011562.
- Dekker L, Sanders E, Lindemans CA, de Koning C, Nierkens S. Naive T Cells in Graft Versus Host Disease and Graft Versus Leukemia: Innocent or Guilty? Front Immunol. 2022 Jun 20;13:893545. doi: 10.3389/fimmu.2022.893545. eCollection 2022.
- Jalili A, Hajifathali A, Mohammadian M, Sankanian G, Sayahinouri M, Dehghani Ghorbi M, Roshandel E, Aghdami N. Virus-Specific T Cells: Promising Adoptive T Cell Therapy Against Infectious Diseases Following Hematopoietic Stem Cell Transplantation. Adv Pharm Bull. 2023 Jul;13(3):469-482. doi: 10.34172/apb.2023.046. Epub 2022 Nov 4.
- Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
- Pfeiffer T, Tzannou I, Wu M, Ramos C, Sasa G, Martinez C, Lulla P, Krance RA, Scherer L, Ruderfer D, Naik S, Bocchini C, Fraser IP, Patel B, Ward D, Wang T, Heslop HE, Leen AM, Omer B. Posoleucel, an Allogeneic, Off-the-Shelf Multivirus-Specific T-Cell Therapy, for the Treatment of Refractory Viral Infections in the Post-HCT Setting. Clin Cancer Res. 2023 Jan 17;29(2):324-330. doi: 10.1158/1078-0432.CCR-22-2415.
- Imlay H, Xie H, Leisenring WM, Duke ER, Kimball LE, Huang ML, Pergam SA, Hill JA, Jerome KR, Milano F, Nichols WG, Pang PS, Hirsch HH, Limaye AP, Boeckh M. Presentation of BK polyomavirus-associated hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. Blood Adv. 2020 Feb 25;4(4):617-628. doi: 10.1182/bloodadvances.2019000802.
- Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.
- Zhou X, Zhang S, Fan J, Zhu X, Hu S. Risk factors for BK virus-associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation: A systematic review and meta-analysis. Clin Transplant. 2023 Nov;37(11):e15121. doi: 10.1111/ctr.15121. Epub 2023 Sep 7.
- Cesaro S, Dalianis T, Hanssen Rinaldo C, Koskenvuo M, Pegoraro A, Einsele H, Cordonnier C, Hirsch HH; ECIL-6 Group. ECIL guidelines for the prevention, diagnosis and treatment of BK polyomavirus-associated haemorrhagic cystitis in haematopoietic stem cell transplant recipients. J Antimicrob Chemother. 2018 Jan 1;73(1):12-21. doi: 10.1093/jac/dkx324.
- van den Brink MR, Velardi E, Perales MA. Immune reconstitution following stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2015;2015:215-9. doi: 10.1182/asheducation-2015.1.215. No abstract available.
- Khan MA, Bashir Q, Chaudhry QU, Ahmed P, Satti TM, Mahmood SK. Review of Haploidentical Hematopoietic Cell Transplantation. J Glob Oncol. 2018 Dec;4:1-13. doi: 10.1200/JGO.18.00130.
- Pulsipher MA, Peters C, Pui CH. High-risk pediatric acute lymphoblastic leukemia: to transplant or not to transplant? Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S137-48. doi: 10.1016/j.bbmt.2010.10.005.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de marzo de 2028
Finalización del estudio (Estimado)
1 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades de la vejiga urinaria
- Cistitis Hemorrágica
- Infecciones
- Enfermedades virales
- Cistitis
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- LB-DTK-BKV-DD-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .