Completado

Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

busulfan

+ cyclophosphamide

+ anti-thymocyte globulin

MedicamentoBiológicoRadiación
Quiénes están siendo reclutados

Linfadenopatía+62

+ Trastornos de insuficiencia de médula ósea

+ Anemia

De 4 a 70 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2 & 3
Intervencional
Inicio del estudio: octubre de 1998
Ver detalles del protocolo

Resumen

Patrocinador PrincipalRoswell Park Cancer Institute
Última actualización: 13 de agosto de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 19 de octubre de 1998

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Compare the morbidity, mortality, and overall outcome of patients with severe aplastic anemia or hematologic malignancy treated with standard vs novel conditioning regimens followed by allogeneic stem cell transplantation. Examine the influence of donor histocompatibility on outcome by comparing matched/related, mismatched/related (with or without T-cell depletion), and matched/unrelated transplants with stratification for type of preparative regimen. Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with the best therapy available. OUTLINE: Patients are stratified according to risk of relapse (standard-risk: acute leukemia in first complete remission, chronic myelogenous leukemia in first chronic phase, lymphoma in sensitive first relapse or second remission, primary or untreated myelodysplastic syndromes, or untreated severe aplastic anemia vs high-risk: all others). Patients are assigned to one of the following conditioning regimens based on diagnosis, risk of relapse, and donor relatedness: Regimen 1: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Regimen 2: Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. Regimen 3: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. Regimen 4: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. Regimen 5: Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. Regimen 6: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. Regimen 7: Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. Regimen 8: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. Regimen 9: Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. All patients then receive donor stem cell infusions on day 0. Some patients may undergo involved-field radiotherapy 4-8 weeks after transplant. Patients will be taken off study after a minimum of 4 years of follow up. PROJECTED ACCRUAL: At least 405 patients will be accrued for this study within 5 years.

NCT00003816
Patrocinador PrincipalRoswell Park Cancer Institute
Última actualización: 13 de agosto de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 361 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 4 a 70 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

LinfadenopatíaTrastornos de insuficiencia de médula óseaAnemiaTrastornos de la coagulación de la sangreTrastornos de las Plaquetas SanguíneasTrastornos de las Proteínas SanguíneasEnfermedades de la Médula ÓseaEnfermedades CardiovascularesTransformación Celular NeoplásicaEnfermedad CrónicaInfecciones por virus ADNNeoplasias ocularesEnfermedades HematológicasEnfermedades hemáticas y linfáticasTrastornos HemorrágicosInfecciones por HerpesviridaeEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosInfeccionesLeucemia LinfocíticaLeucemia MieloideEnfermedades LinfáticasTrastornos LinfoproliferativosEnfermedades y Anomalías Congénitas, Hereditarias y NeonatalesNeoplasias por tipo histológicoNeoplasias por SitioProcesos NeoplásicosParaproteinemiasProcesos PatológicosCondiciones Patológicas, Signos y SíntomasTrombocitosisInfecciones por Virus TumoralesEnfermedades VascularesEnfermedades ViralesLeucemia de células BLeucemia de Células TLeucemia Mieloide Crónica BCR-ABL PositivaHistiocitosisTrastornos Histiocíticos MalignosAnomalías CongénitasAnemia AplásicaAnemia RefractariaAnemia Refractaria con Exceso de BlastosCrisis BlásticaLinfoma de BurkittLinfadenopatía InmunoblásticaLeucemiaLinfomaLinfoma FolicularLinfoma no HodgkinMacroglobulinemia de WaldenströmMicosis FungoideSíndromes MielodisplásicosTrastornos MieloproliferativosNeoplasiasPolicitemia VeraSíndrome de SézaryTrombocitemia EsencialLeucemia linfocítica crónica de células BLeucemia Bifenotípica AgudaLeucemia ProlinfocíticaLeucemia mieloide, fase aceleradaLeucemia mieloide crónica, fase crónicaLeucemia mieloide agudaLeucemia Mielomonocítica Crónica

Criterios

DISEASE CHARACTERISTICS: Diagnosis of one of the following: Severe aplastic anemia as defined by either of the following: Marrow cellularity (< 25% [or 25-50% cellularity with < 30% of remaining cells hematopoietic in origin]) At least 2 of the following abnormal peripheral blood counts: Reticulocyte count < 1% (corrected for hematocrit) Platelet count < 20,000/mm^3 Neutrophil count < 500/mm^3 Histologically confirmed hematologic malignancy, including any of the following: Acute leukemia Resistant or recurrent disease after combination chemotherapy with at least one standard regimen OR in first remission and at high risk of relapse Acute myeloid leukemia (AML) (antecedent myelodysplastic syndromes [MDS], secondary AML, or high-risk cytogenetic abnormalities) Acute lymphoblastic leukemia (ALL) (high-risk cytogenetic abnormalities) Chronic myeloid leukemia (CML) Chronic phase, accelerated phase, or blast phase Myeloproliferative disorders or MDS, including any of the following: Myelofibrosis Polycythemia vera* Essential thrombocythemia* Refractory anemia Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia NOTE: * Only if transformed to AML or MDS Lymphoproliferative disease Recurrent or persistent, symptomatic disease after first-line chemotherapy, including any of the following: Chronic lymphocytic leukemia (CLL) (≥ 20% marrow involvement) Waldenstrom macroglobulinemia Low-grade non-Hodgkin lymphoma Intermediate or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria: Resistant or recurrent disease after combination chemotherapy with one standard regimen Lymphoblastic lymphoma or small noncleaved cell lymphoma in first remission and at high risk of relapse CNS disease Bone marrow disease and LDH greater than 300 Solid tumor that would otherwise be treated on RPCI-DS-9115 (or equivalent autologous stem transplant protocol) AND has a syngeneic donor Autologous bone marrow transplant not possible (or desirable) due to 1 of the following: History of marrow tumor Inadequate marrow dose Abnormal marrow histology or function prior to storage Thrombocytopenia or leukopenia Marrow cellularity < 20% Histocompatible donor identified Well-matched donor, as defined by 1 of the following: Family member matched for 5 or 6 HLA specificities (A, B, DR)* Unrelated donor meeting compatibility criteria of the National Marrow Donor Program (matched for HLA A, B, and DRB1 antigens)* Identical twin sibling If a compatible cord blood donor is identified and there is no suitable unrelated donor available, patient may receive cord blood transplant NOTE: *Patients ≤ 25 years of age may be singly mismatched at the A or B loci NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 4 to 70 Performance status: Zubrod 0-2 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin < 3 times normal (unless due to disease) Alkaline phosphatase < 3 times normal (unless due to disease) SGOT < 3 times normal (unless due to disease) Hepatitis B surface antigen negative No severe hepatic disease that would preclude study participation Renal: Creatinine normal Creatinine clearance ≥ 50 mL/min No severe renal disease that would preclude study participation Cardiovascular: Cardiac ventricular ejection fraction ≥ 50% by MUGA or echocardiogram No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction, congestive heart failure, symptomatic angina, life threatening arrhythmia, or hypertension within the past 6 months) Pulmonary: DLCO or DLVA ≥ 50% predicted (corrected for hemoglobin or alveolar ventilation) Other: No serious concurrent medical or psychiatric illness No other serious organ dysfunction (unless due to underlying disease), including the following: Uncontrolled bacterial, viral, or fungal infection Uncontrolled peptic ulcer disease Uncontrolled diabetes mellitus HIV negative Cytomegalovirus status known Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Pretransplant cytoreductive chemotherapy allowed for patients with relapsed or refractory disease Endocrine therapy: Not specified Radiotherapy: Not eligible for total-body irradiation if prior radiotherapy exceeded the following limits: Mediastinum: 3,600 cGy Heart: 3,600 cGy Whole lungs: 1,200 cGy Small bowel: 3,600 cGy Kidneys: 1,200 cGy Whole liver: 1,600 cGy Cranial spinal: 3,600 cGy Brain: 4,000 cGy Retina: 4,000 cGy Surgery: Not specified

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

9 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

Grupo II

Experimental
Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.

Grupo III

Experimental
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.

Grupo IV

Experimental
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.

Grupo 5

Experimental
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.

Grupo 6

Experimental
Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.

Grupo 7

Experimental
Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.

Grupo 8

Experimental
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.

Grupo 9

Experimental
Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Roswell Park Cancer Institute

Buffalo, United StatesAbrir Roswell Park Cancer Institute en Google Maps
Completado1 Centros de Estudio