A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 11
- 主要终点
- Overall Survival
研究概览
简要总结
This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF) for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 15 years and < 71 years at the time of signing the informed consent form
- •Partially HLA-mismatched unrelated donor: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of 4/8 at HLA-A, -B, -C, and -DRB1 is required
- •Product planned for infusion is bone marrow
- •Disease and disease status:
- •Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma; acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute undifferentiated leukemia (AUL)
- •Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with de novo MDS who have or have previously had Intermediate-2 or High risk disease as determined by the International Prognostic Scoring System (IPSS). Current Intermediate-2 or High risk disease is not a requirement; Subjects must have < 20% bone marrow blasts, assessed within 60 days of informed consent; Subjects may have received prior therapy for the treatment of MDS prior to enrollment
- •Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial response (PR) if FIC is to be used
- •Chronic myeloid leukemia (CML) in 1st or subsequent chronic phase characterized by <10% blasts in the blood or bone marrow.
- •Chemotherapy-sensitive lymphoma in status other than 1st CR
- •Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)
- •Adequate organ function defined as:
- •Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or left ventricular shortening fraction (LVFS) ≥ 25%
- •Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume (FEV1), forced vital capacity (FVC) ≥ 50% predicted by pulmonary function tests (PFTs)
- •Hepatic: total bilirubin ≤ 2.5 mg/dL, and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) < 5 x upper limit of (ULN) (unless disease related)
- •Renal: serum creatinine (SCr) within normal range for age (see table 2.3). If SCr is outside normal range for age, creatinine clearance (CrCl) > 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula for those aged ≥ 18 years; by Original Schwartz estimate for those < 18 years))
- •Subjects ≥ 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian permission must be obtained for subjects < 18 years of age. Pediatric subjects will be included in age appropriate discussion in order to obtain assent.
- •Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a hematologic malignancy who meets all other eligibility requirements must:
- •Receive only RIC regimen (i.e. Regimen A)
- •Be willing to comply with effective antiretroviral therapy (ARV)
- •Have achieved a sustained virologic response for 12 weeks after cessation of hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C)
排除标准
- •HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor available. This exclusion does not apply to HIV-positive subjects who have a CCR5delta32 homozygous donor.
- •Autologous HCT < 3 months prior to the time of signing the informed consent form
- •Females who are breast-feeding or pregnant
- •HIV-positive subjects:
- •Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may pose an excessive risk for transplantation-related morbidity as determined by the Treatment Review Committee (see Appendix D).
- •Untreatable HIV infection due to multidrug ARV resistance. Subjects with a detectable or standard viral load > 750 copies/mL should be evaluated with an HIV drug resistance test (HIV-1 genotype). The results should be included as part of the ARV review (described in Appendix D).
- •May not be currently prescribed ritonavir, cobacistat and/or zidovudine
- •Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
- •Prior allogeneic HCT
- •History of primary idiopathic myelofibrosis
- •MDS subjects may not receive RIC and must be < 50 years of age at the time of signing the informed consent form
研究组 & 干预措施
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Fludarabine (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5 (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Total Body Irradiation (TBI) 200cGy on Day -1 (Radiation)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Infusion of non-T-cell depleted bone marrow on Day 0 (Procedure)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4 (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Sirolimus (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Mycophenolate mofetil (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: G-CSF (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Pre-HCT Mesna on Days -6 and -5 (Drug)
Regimen A (RIC: Flu/Cy/TBI)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- Total Body Irradiation (TBI) 200cGy on Day -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Mesna (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Infusion of non-T-cell depleted bone marrow on Day 0 (Procedure)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Busulfan (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Cyclophosphamide 50mg/kg/day IV on Days -2,-1 (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4 (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Sirolimus (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Mycophenolate mofetil (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: G-CSF (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Pre-HCT Mesna on Days -2 and -1 (Drug)
Regimen B 2a (FIC: Bu/Cy)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Cyclophosphamide 50mg/kg/day IV on Days -2,-1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Mesna (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Fludarabine (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Infusion of non-T-cell depleted bone marrow on Day 0 (Procedure)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Busulfan (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4 (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Sirolimus (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Mycophenolate mofetil (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: G-CSF (Drug)
Regimen B 2b (FIC: Bu/Flu)
- Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO)
- Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Mesna (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Infusion of non-T-cell depleted bone marrow on Day 0 (Procedure)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Cyclophosphamide 50mg/kg/day IV on Days -5,-4 (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1 (Radiation)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4 (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: G-CSF (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Sirolimus (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Mycophenolate mofetil (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Pre-HCT Mesna on Days -5 and -4 (Drug)
Regimen C (FIC: Cy/TBI)
- Cyclophosphamide 50mg/kg/day IV on Days -5,-4
- Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
- Infusion of non-T-cell depleted bone marrow on Day 0
Although a schedule is proposed above, the regimen can be given according to institutional standards as long as the prescribed doses are the same as in the recommended regimen above.
干预措施: Post-HCT Mesna (Drug)
结局指标
主要结局
Overall Survival
时间窗: 365 days post transplant
Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
次要结局
- Progression-free Survival(180 days and 365 days post-transplant)
- Transplant-related Mortality(100 days, 180 days, and 365 days post-transplant)
- Cumulative Incidence of Neutrophil Recovery(100 days and 365 days post transplant)
- Cumulative Incidence of Platelet Recovery(100 days and 365 days post transplant)
- Cumulative Incidence of Acute GVHD(100 days post-transplant)
- Grades II-IV Acute GVHD(100 days)
- Grades III-IV Acute GVHD(100 days)
- Cumulative Incidence of Chronic GVHD(180 days and 365 days post-transplant)
- Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 CMV Reactivation or Infection(100 days, 180 days, and 365 days)
- Cumulative Incidences of Viral Reactivations and Infections: Grade 3 CMV Infection(100 days, 180 days, and 365 days)
- Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 EBV Infection(100 days, 180 days, and 365 days)
- Cumulative Incidences of Viral Reactivations and Infections: Grade 2 BK Virus Infection(100 days, 180 days, 365 days)
- Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 Adenovirus Infection(100 days, 180 days, and 365 days)
- Cumulative Incidences of Viral Reactivations and Infections: Grade 2 HHV-6 Infection(100 days, 180 days, 365 days)
- Cumulative Incidence of Relapse/Progression(180 days and 365 days post-transplant)
- Cumulative Incidences of Thrombotic Microangiopathy (TMA) and Hepatic Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)(365 days post transplant)
- Cumulative Incidence of Primary Graft Failure(56 days post-transplant)
- Donor Chimerism(28 days, 56 days, 100 days, 180 days, and 365 days post-transplant)
- Peripheral Blood Chimerism(56 days post-transplant)
- Proportion of Subjects Proceeding to Transplant(Pre-HCT)
- Time From Search to Donor Identification(Pre-HCT)
- Donor Selection Characteristics: HLA Match(Pre-HCT)
- Donor Selection Characteristics: Donor Age(Pre-HCT)
- Donor Selection Characteristics: Donor Age, Categorical(Pre-HCT)
- Donor Selection Characteristics: Donor Weight(Pre-HCT)
- Donor Selection Characteristics: Donor Sex(Pre-HCT)
- Donor Selection Characteristics: Donor and Recipient Sex(Pre-HCT)
- Donor Selection Characteristics: Donor and Recipient CMV Serostatus(Pre-HCT)
- Donor Selection Characteristics: Donor and Recipient ABO Blood Match(Pre-HCT)
- Donor Clonal Hematopoiesis(100 days and 365 days post-transplant)
- Subgroup Analysis of HIV-positive Subjects(365 days post transplant)