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NCT00719888 · OUTCOME

Neutrophil Engraftment

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease · Source last updated 2025-03-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Days post-transplant
Interval / dispersion
Full Range
Time frame
Up to day 42 post-transplant

What was measured

Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.

Analysis population: Analysis population is all patients who underwent UCB transplant and experienced ANC engraftment by day 42 post-transplant on study. 4 patients did engraft ANC after day 42 post-transplant, but are not included in this analysis due to protocol definition of engraftment period.

Groups in this outcome

Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant

Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies

Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant

Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies

Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant

Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies

Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant

Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant30
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant16
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant65
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant8

Reported measurements

Source class 1
Values in Days post-transplant · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant19Not reported1242Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant19Not reported1340Not reported
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant22Not reported1239Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant20Not reported1529Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12
        upper Limit
        42
        value
        19
      2. group Id
        OG001
        lower Limit
        13
        upper Limit
        40
        value
        19
      3. group Id
        OG002
        lower Limit
        12
        upper Limit
        39
        value
        22
      4. group Id
        OG003
        lower Limit
        15
        upper Limit
        29
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      65
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.
dispersion Type
Full Range
groups
  1. description
    Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant
  2. description
    Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant
  3. description
    Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
    id
    OG002
    title
    Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant
  4. description
    Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
    id
    OG003
    title
    Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant
param Type
MEDIAN
population Description
Analysis population is all patients who underwent UCB transplant and experienced ANC engraftment by day 42 post-transplant on study. 4 patients did engraft ANC after day 42 post-transplant, but are not included in this analysis due to protocol definition of engraftment period.
reporting Status
POSTED
time Frame
Up to day 42 post-transplant
title
Neutrophil Engraftment
type
SECONDARY
unit Of Measure
Days post-transplant

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Preserved source evidence · Not medical advice