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NCT00741455 · OUTCOME

Number of Participants Who Achieve Complete Donor Chimerism

Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies · Source last updated 2020-11-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Post-transplant days +30, +60, +100, +180 and +365

What was measured

Complete donor chimerism

Groups in this outcome

Study Treatment

Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k

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

Analysis denominator · Participants

GroupSource count
Study Treatment17

Reported measurements

Complete Chimerism 30 Days Post Transplant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment2Not reportedNot reportedNot reportedNot reported
Complete Chimerism 60 Days Post Transplant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment2Not reportedNot reportedNot reportedNot reported
Complete Chimerism 100 Days Post Transplant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment3Not reportedNot reportedNot reportedNot reported
Complete Chimerism 180 Days Post Transplant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment3Not reportedNot reportedNot reportedNot reported
Complete Chimerism 365 Days Post Transplant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment4Not reportedNot reportedNot reportedNot reported
Chimerism Unknown
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment1Not reportedNot reportedNot reportedNot reported
Did not achieve complete donor chimerism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Study Treatment2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Complete Chimerism 30 Days Post Transplant
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Complete Chimerism 60 Days Post Transplant
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Complete Chimerism 100 Days Post Transplant
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Complete Chimerism 180 Days Post Transplant
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Complete Chimerism 365 Days Post Transplant
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Chimerism Unknown
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Did not achieve complete donor chimerism
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Complete donor chimerism
groups
  1. description
    Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k
    id
    OG000
    title
    Study Treatment
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Post-transplant days +30, +60, +100, +180 and +365
title
Number of Participants Who Achieve Complete Donor Chimerism
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice