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NCT00580034 · OUTCOME

Toxicity

Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath · Source last updated 2014-06-03

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.

Analysis population: Cohort of subjects on the study who received \>/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.

Groups in this outcome

Campath Purged Non-myeloablative ASCT

Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.

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

Analysis denominator · Participants

GroupSource count
Campath Purged Non-myeloablative ASCT86

Reported measurements

Acute Graft versus Host Disease (aGvHD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT5Not reportedNot reportedNot reportedNot reported
Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT3Not reportedNot reportedNot reportedNot reported
Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT10Not reportedNot reportedNot reportedNot reported
Graft Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT17Not reportedNot reportedNot reportedNot reported
Cardiac
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT3Not reportedNot reportedNot reportedNot reported
Multi-organ failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT1Not reportedNot reportedNot reportedNot reported
Hepatic Veno-Occlusive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT1Not reportedNot reportedNot reportedNot reported
Post-transplant lymphoproliferative disorder
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT2Not reportedNot reportedNot reportedNot reported
Acute respiratory distress syndrome
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Campath Purged Non-myeloablative ASCT2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Acute Graft versus Host Disease (aGvHD)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Sepsis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Infection
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Graft Failure
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Cardiac
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Multi-organ failure
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hepatic Veno-Occlusive Disease
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Post-transplant lymphoproliferative disorder
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Acute respiratory distress syndrome
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.
groups
  1. description
    Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    OG000
    title
    Campath Purged Non-myeloablative ASCT
param Type
NUMBER
population Description
Cohort of subjects on the study who received \>/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.
reporting Status
POSTED
time Frame
1 year
title
Toxicity
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice