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NCT00719888 · OUTCOME

Change in Level of Chimerism at Multiple Time Points

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
percentage chimerism (%)
Interval / dispersion
Full Range
Time frame
Baseline up to 2 years post-transplant

What was measured

Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Analysis population: Participants who received UCBT on study with chimerism data available within window as specified in protocol.

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 Transplant33
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant17
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant72
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant10

Reported measurements

Combined median of CD3 at days (24, 56, 80, 180, 365, 730)
Values in percentage chimerism (%) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant100Not reported44100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant100Not reported69100Not reported
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant100Not reported67100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant100Not reported88100Not reported
Combined median of CD14 at days (24, 56, 80, 180, 365, 730)
Values in percentage chimerism (%) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant100Not reported0100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant100Not reported100100Not reported
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant100Not reported91100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant100Not reported100100Not reported
Combined median of CD33 at days (24, 56, 80, 180, 365, 730)
Values in percentage chimerism (%) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant100Not reported99100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant100Not reported98100Not reported
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant100Not reported50100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant100Not reported91100Not reported
Combined median of CD56 at days (24, 56, 80, 180, 365, 730)
Values in percentage chimerism (%) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant100Not reported0100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant100Not reported100100Not reported
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant100Not reported60100Not reported
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant100Not reported90100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        69
        upper Limit
        100
        value
        100
      3. group Id
        OG002
        lower Limit
        67
        upper Limit
        100
        value
        100
      4. group Id
        OG003
        lower Limit
        88
        upper Limit
        100
        value
        100
    title
    Combined median of CD3 at days (24, 56, 80, 180, 365, 730)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        100
        upper Limit
        100
        value
        100
      3. group Id
        OG002
        lower Limit
        91
        upper Limit
        100
        value
        100
      4. group Id
        OG003
        lower Limit
        100
        upper Limit
        100
        value
        100
    title
    Combined median of CD14 at days (24, 56, 80, 180, 365, 730)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        98
        upper Limit
        100
        value
        100
      3. group Id
        OG002
        lower Limit
        50
        upper Limit
        100
        value
        100
      4. group Id
        OG003
        lower Limit
        91
        upper Limit
        100
        value
        100
    title
    Combined median of CD33 at days (24, 56, 80, 180, 365, 730)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        100
        upper Limit
        100
        value
        100
      3. group Id
        OG002
        lower Limit
        60
        upper Limit
        100
        value
        100
      4. group Id
        OG003
        lower Limit
        90
        upper Limit
        100
        value
        100
    title
    Combined median of CD56 at days (24, 56, 80, 180, 365, 730)
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      72
    4. group Id
      OG003
      value
      10
    units
    Participants
description
Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. 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
Participants who received UCBT on study with chimerism data available within window as specified in protocol.
reporting Status
POSTED
time Frame
Baseline up to 2 years post-transplant
title
Change in Level of Chimerism at Multiple Time Points
type
SECONDARY
unit Of Measure
percentage chimerism (%)

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Preserved source evidence · Not medical advice