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NCT02793544 · REGISTRY CONDITION SEARCH

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2025-08-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Transplant-related Mortality

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outcome · POSTED

Cumulative Incidence of Neutrophil Recovery

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outcome · POSTED

Cumulative Incidence of Platelet Recovery

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outcome · POSTED

Cumulative Incidence of Acute GVHD

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outcome · POSTED

Grades II-IV Acute GVHD

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outcome · POSTED

Grades III-IV Acute GVHD

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outcome · POSTED

Cumulative Incidence of Chronic GVHD

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outcome · POSTED

Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 CMV Reactivation or Infection

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outcome · POSTED

Cumulative Incidences of Viral Reactivations and Infections: Grade 3 CMV Infection

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outcome · POSTED

Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 EBV Infection

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outcome · POSTED

Cumulative Incidences of Viral Reactivations and Infections: Grade 2 BK Virus Infection

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outcome · POSTED

Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 Adenovirus Infection

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outcome · POSTED

Cumulative Incidences of Viral Reactivations and Infections: Grade 2 HHV-6 Infection

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outcome · POSTED

Cumulative Incidence of Relapse/Progression

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outcome · POSTED

Cumulative Incidences of Thrombotic Microangiopathy (TMA) and Hepatic Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)

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outcome · POSTED

Cumulative Incidence of Primary Graft Failure

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outcome · POSTED

Donor Chimerism

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outcome · POSTED

Peripheral Blood Chimerism

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outcome · POSTED

Proportion of Subjects Proceeding to Transplant

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outcome · POSTED

Time From Search to Donor Identification

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outcome · POSTED

Donor Selection Characteristics: HLA Match

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outcome · POSTED

Donor Selection Characteristics: Donor Age

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outcome · POSTED

Donor Selection Characteristics: Donor Age, Categorical

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outcome · POSTED

Donor Selection Characteristics: Donor Weight

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outcome · POSTED

Donor Selection Characteristics: Donor Sex

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outcome · POSTED

Donor Selection Characteristics: Donor and Recipient Sex

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outcome · POSTED

Donor Selection Characteristics: Donor and Recipient CMV Serostatus

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outcome · POSTED

Donor Selection Characteristics: Donor and Recipient ABO Blood Match

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outcome · POSTED

Donor Clonal Hematopoiesis

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outcome · POSTED

Subgroup Analysis of HIV-positive Subjects

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Age ≥ 15 years and \< 71 years at the time of signing the informed consent form 2. 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 3. Product planned for infusion is bone marrow 4. Disease and disease status: 1. 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) 2. 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 3. Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial response (PR) if FIC is to be used 4. Chronic myeloid leukemia (CML) in 1st or subsequent chronic phase characterized by \<10% blasts in the blood or bone marrow. 5. Chemotherapy-sensitive lymphoma in status other than 1st CR 5. Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A) 6. Adequate organ function defined as: 1. 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% 2. 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) 3. 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) 4. 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)) 7. 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. 8. Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a hematologic malignancy who meets all other eligibility requirements must: 1. Receive only RIC regimen (i.e. Regimen A) 2. Be willing to comply with effective antiretroviral therapy (ARV) 3. Have achieved a sustained virologic response for 12 weeks after cessation of hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C) Exclusion Criteria: 1. 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. 2. Autologous HCT \< 3 months prior to the time of signing the informed consent form 3. Females who are breast-feeding or pregnant 4. HIV-positive subjects: 1. 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). 2. 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). 3. May not be currently prescribed ritonavir, cobacistat and/or zidovudine 5. Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings) 6. Prior allogeneic HCT 7. History of primary idiopathic myelofibrosis 8. MDS subjects may not receive RIC and must be \< 50 years of age at the time of signing the informed consent form
healthy Volunteers
false
maximum Age
70 Years
minimum Age
15 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    1. Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2 2. Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5 3. Total Body Irradiation (TBI) 200cGy on Day -1 4. 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.
    intervention Names
    1. Drug: Fludarabine
    2. Drug: Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
    3. Radiation: Total Body Irradiation (TBI) 200cGy on Day -1
    4. Procedure: Infusion of non-T-cell depleted bone marrow on Day 0
    5. Drug: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4
    6. Drug: Sirolimus
    7. Drug: Mycophenolate mofetil
    8. Drug: G-CSF
    9. Drug: Pre-HCT Mesna on Days -6 and -5
    10. Drug: Post-HCT Mesna
    label
    Regimen A (RIC: Flu/Cy/TBI)
    type
    ACTIVE_COMPARATOR
  2. description
    1. Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO) 2. Cyclophosphamide 50mg/kg/day IV on Days -2,-1 3. 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.
    intervention Names
    1. Procedure: Infusion of non-T-cell depleted bone marrow on Day 0
    2. Drug: Busulfan
    3. Drug: Cyclophosphamide 50mg/kg/day IV on Days -2,-1
    4. Drug: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4
    5. Drug: Sirolimus
    6. Drug: Mycophenolate mofetil
    7. Drug: G-CSF
    8. Drug: Pre-HCT Mesna on Days -2 and -1
    9. Drug: Post-HCT Mesna
    label
    Regimen B 2a (FIC: Bu/Cy)
    type
    ACTIVE_COMPARATOR
  3. description
    1. Busulfan ≥ 9mg/kg total dose on Days -6, -5, -4, -3 (IV or PO) 2. Fludarabine 30 mg/m2/day IV on Days -6, -5, -4, -3, -2 3. 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.
    intervention Names
    1. Drug: Fludarabine
    2. Procedure: Infusion of non-T-cell depleted bone marrow on Day 0
    3. Drug: Busulfan
    4. Drug: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4
    5. Drug: Sirolimus
    6. Drug: Mycophenolate mofetil
    7. Drug: G-CSF
    8. Drug: Post-HCT Mesna
    label
    Regimen B 2b (FIC: Bu/Flu)
    type
    ACTIVE_COMPARATOR
  4. description
    1. Cyclophosphamide 50mg/kg/day IV on Days -5,-4 2. Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1 3. 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.
    intervention Names
    1. Procedure: Infusion of non-T-cell depleted bone marrow on Day 0
    2. Drug: Cyclophosphamide 50mg/kg/day IV on Days -5,-4
    3. Radiation: Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
    4. Drug: Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4
    5. Drug: Sirolimus
    6. Drug: Mycophenolate mofetil
    7. Drug: G-CSF
    8. Drug: Pre-HCT Mesna on Days -5 and -4
    9. Drug: Post-HCT Mesna
    label
    Regimen C (FIC: Cy/TBI)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    2. Regimen B 2b (FIC: Bu/Flu)
    description
    * Fludarabine 30 mg/m2/day (adjusted for renal function) is administered over a 30-60 minute IV infusion on Days -6 through -2 (maximum cumulative dose, 150 mg/m2). * The body surface area (BSA) for fludarabine dosing is based on adjusted ideal body weight (IBW) (Appendix K). * creatinine clearance may change during the days fludarabine is given. Adjustment in fludarabine dose due to creatinine changes during conditioning is permitted.
    name
    Fludarabine
    other Names
    1. Fludara®
    type
    DRUG
  2. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    description
    * Cy 14.5 mg/kg/day is administered as a 1-2 hour IV infusion on Days -6 and -5 after hydration. * Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy. * Hydration prior to Cy may be given according to institutional guideline. * Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight.
    name
    Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
    other Names
    1. Cytoxan®
    type
    DRUG
  3. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    description
    * 200 cGy TBI is administered in a single fraction on Day -1. * Radiation sources, dose rates, and shielding follow institutional practice.
    name
    Total Body Irradiation (TBI) 200cGy on Day -1
    type
    RADIATION
  4. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    2. Regimen B 2a (FIC: Bu/Cy)
    3. Regimen B 2b (FIC: Bu/Flu)
    4. Regimen C (FIC: Cy/TBI)
    description
    * On Day 0, the harvested bone marrow is infused. * Donor bone marrow will be harvested with a target yield of 4 x 108 nucleated cells/kg recipient weight. * The lowest acceptable nucleated cells yield is 1.5 x 108 cells/kg recipient weight.
    name
    Infusion of non-T-cell depleted bone marrow on Day 0
    type
    PROCEDURE
  5. arm Group Labels
    1. Regimen B 2a (FIC: Bu/Cy)
    2. Regimen B 2b (FIC: Bu/Flu)
    description
    * Busulfan ≥ 9mg/kg total dose (IV or PO) on Days -6, -5, -4, -3 (PK monitoring required to achieve a daily area under the curve (AUC) target of 4800-5300 μM\*min (Perkins et al., 2012)) * Busulfan dosing is based on adjusted IBW (Appendix K)
    name
    Busulfan
    other Names
    1. Busulfex®
    type
    DRUG
  6. arm Group Labels
    1. Regimen B 2a (FIC: Bu/Cy)
    description
    * Cy 50mg/kg/day is administered as a 1-2 hour IV infusion on Days -2 and -1 after hydration. * Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy. * Hydration prior to Cy may be given according to institutional guideline. * Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight.
    name
    Cyclophosphamide 50mg/kg/day IV on Days -2,-1
    other Names
    1. Cytoxan®
    type
    DRUG
  7. arm Group Labels
    1. Regimen C (FIC: Cy/TBI)
    description
    * Cy 50mg/kg/day is administered as a 1-2 hour IV infusion on Days -5 and -4 after hydration. * Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy. * Hydration prior to Cy may be given according to institutional guideline. * Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight.
    name
    Cyclophosphamide 50mg/kg/day IV on Days -5,-4
    other Names
    1. Cytoxan®
    type
    DRUG
  8. arm Group Labels
    1. Regimen C (FIC: Cy/TBI)
    description
    * 200cGy TBI is administered in twice daily on Days -3, -2, and -1. * Radiation sources, dose rates, and shielding follow institutional practice.
    name
    Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1
    type
    RADIATION
  9. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    2. Regimen B 2a (FIC: Bu/Cy)
    3. Regimen B 2b (FIC: Bu/Flu)
    4. Regimen C (FIC: Cy/TBI)
    description
    * Cy 50mg/kg IV, over 1-2 hours (depending on volume), is given on Day+3 (ideally between 60 and 72 hours after bone marrow infusion) and on Day+4 (approximately 24 hours after Day+3 Cy). * Hydration with Cy, management of volume status, and monitoring for hemorrhagic cystitis will follow institutional standards. * Mesna is required. Mesna IV dose must be ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy. * Cy is dosed according to IBW, unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual body weight.
    name
    Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4
    type
    DRUG
  10. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    2. Regimen B 2a (FIC: Bu/Cy)
    3. Regimen B 2b (FIC: Bu/Flu)
    4. Regimen C (FIC: Cy/TBI)
    description
    * Sirolimus dosing is based on adjusted IBW (Appendix K). * Sirolimus prophylaxis is discontinued after the last dose on Day+180, or may be continued if there is GVHD. For subjects ≥ 18 years old: * A one-time sirolimus loading dose, 6 mg PO, is given on Day+5, at least 24 hours after Cy completion. * Sirolimus is then continued at a maintenance dose (starting dose 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by high performance liquid chromatography (HPLC) or immunoassay. For subjects \< 18 years old: * A one-time sirolimus loading dose, 3 mg/m2 PO with the dose not to exceed 6 mg, is given on Day+5, at least 24 hours after Cy completion. * Sirolimus is then continued at a maintenance dose (starting dose 1 mg/m2 PO QD, maximum 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by HPLC or immunoassay.
    name
    Sirolimus
    other Names
    1. rapamycin
    2. Rapamune®
    type
    DRUG
  11. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    2. Regimen B 2a (FIC: Bu/Cy)
    3. Regimen B 2b (FIC: Bu/Flu)
    4. Regimen C (FIC: Cy/TBI)
    description
    MMF begins on Day+5, at least 24 hours after completion of PTCy. MMF dose is 15 mg/kg PO TID (adjusted IBW (Appendix K)) with total daily dose not to exceed 3 grams (i.e. maximum 1 g PO TID). An equivalent IV dose (1:1 conversion) may instead be given. MMF prophylaxis is discontinued after the last dose on Day+35, or may be continued if there is GVHD.
    name
    Mycophenolate mofetil
    other Names
    1. MMF
    2. Cellcept®
    type
    DRUG
  12. arm Group Labels
    1. Regimen A (RIC: Flu/Cy/TBI)
    2. Regimen B 2a (FIC: Bu/Cy)
    3. Regimen B 2b (FIC: Bu/Flu)
    4. Regimen C (FIC: Cy/TBI)
    description
    Granulocyte-colony stimulating factor (G-CSF): filgrastim or a biosimilar begins on Day+5 at a dose of 5 mcg/kg/day (actual body weight) IV or subcutaneously (SC) (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is ≥ 1,000/mm3 over the course of 3 consecutive days. Additional G-CSF may be administered as warranted.
    name
    G-CSF
    other Names
    1. filgrastim
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
80
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Overall Survival
    time Frame
    365 days post transplant
secondary Outcomes
  1. description
    Time from HCT until the documentation of disease progression / relapse or death due to any cause, whichever occurs first. Progression-free survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
    measure
    Progression-free Survival
    time Frame
    180 days and 365 days post-transplant
  2. description
    Death without evidence of disease progression or recurrence. A cumulative incidence will be computed along with a 90% CI.
    measure
    Transplant-related Mortality
    time Frame
    100 days, 180 days, and 365 days post-transplant
  3. description
    Achieving a donor derived ANC ≥ 500/mm3 for 3 consecutive laboratory values on different days. A cumulative incidence will be computed along with a 90% CI.
    measure
    Cumulative Incidence of Neutrophil Recovery
    time Frame
    100 days and 365 days post transplant
  4. description
    Achieving a platelet count ≥ 20,000/μL for 3 consecutive laboratory values on different days (with no platelet transfusions in the preceding seven days). A cumulative incidence will be computed along with a 90% CI.
    measure
    Cumulative Incidence of Platelet Recovery
    time Frame
    100 days and 365 days post transplant
  5. description
    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI. Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.
    measure
    Cumulative Incidence of Acute GVHD
    time Frame
    100 days post-transplant
  6. description
    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.
    measure
    Grades II-IV Acute GVHD
    time Frame
    100 days
  7. description
    Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.
    measure
    Grades III-IV Acute GVHD
    time Frame
    100 days
  8. description
    Per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe). A cumulative incidence will be computed along with a 90% CI. 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.
    measure
    Cumulative Incidence of Chronic GVHD
    time Frame
    180 days and 365 days post-transplant
  9. description
    Grade 2: Clinically active CMV infection (e.g. symptoms, cytopenias) or CMV Viremia not decreasing by at least 2/3 of the baseline value after 2 weeks of therapy; Grade 3: CMV end-organ involvement (pneumonitis, enteritis, retinitis). A cumulative incidence will be computed along with a 90% CI. 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.
    measure
    Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 CMV Reactivation or Infection
    time Frame
    100 days, 180 days, and 365 days
  10. description
    CMV end-organ involvement (pneumonitis, enteritis, retinitis) ). A cumulative incidence will be computed along with a 90% CI. 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.
    measure
    Cumulative Incidences of Viral Reactivations and Infections: Grade 3 CMV Infection
    time Frame
    100 days, 180 days, and 365 days
  11. description
    Grade 2: EBV reactivation requiring institution of therapy with rituximab; Grade 3: EBV post-transplant lymphoproliferative disorder). A cumulative incidence will be computed along with a 90% CI. 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.
    measure
    Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 EBV Infection
    time Frame
    100 days, 180 days, and 365 days
  12. description
    BK viremia or viruria with clinical consequence requiring prolonged therapy and/or surgical intervention). A cumulative incidence will be computed along with a 90% CI.
    measure
    Cumulative Incidences of Viral Reactivations and Infections: Grade 2 BK Virus Infection
    time Frame
    100 days, 180 days, 365 days
Full study description
brief Summary
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.
Source references
references
  1. citation
    Shaw BE, Jimenez-Jimenez AM, Burns LJ, Logan BR, Khimani F, Shaffer BC, Shah NN, Mussetter A, Tang XY, McCarty JM, Alavi A, Farhadfar N, Jamieson K, Hardy NM, Choe H, Ambinder RF, Anasetti C, Perales MA, Spellman SR, Howard A, Komanduri KV, Luznik L, Norkin M, Pidala JA, Ratanatharathorn V, Confer DL, Devine SM, Horowitz MM, Bolanos-Meade J. National Marrow Donor Program-Sponsored Multicenter, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation Using Post-Transplant Cyclophosphamide. J Clin Oncol. 2021 Jun 20;39(18):1971-1982. doi: 10.1200/JCO.20.03502. Epub 2021 Apr 27.
    pmid
    33905264
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-acute-undifferentiated-leukemia-000.json
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      source json pointer
      /studies/23/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e06d531c393cac0ae0c3f5f04bc4ef110e771a7dfc8e3716f0856781cbf6b772
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-eab34baf2678b82abb97
      requested nct id
      NCT02793544
      primary nct id
      NCT02793544
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      1f6ffef8d557bd3ff6e7738a80f73b58dddfc3fab889f2661577c6dd238f078c
      payload sha256
      11d006aa2e6ce4a764b91511652291a90ce951555f943d5c613787e47a602c3d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-eab34baf2678b82abb97
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02793544
      occurrences
      1. context exact
        NCT02793544
        end
        11
        exact text
        NCT02793544
        start
        0
      offset unit
      unicode_code_points
      query cond
      Infant Acute Undifferentiated Leukemia
      query disease state id
      ds-infant-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-infant-acute-undifferentiated-leukemia-000.json
      source file sha256
      1f6ffef8d557bd3ff6e7738a80f73b58dddfc3fab889f2661577c6dd238f078c
      source json pointer
      /studies/13/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e06d531c393cac0ae0c3f5f04bc4ef110e771a7dfc8e3716f0856781cbf6b772

    Preserved source evidence · Not medical advice