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NCT00597714 · OUTCOME

Graft Versus Host Disease

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant · Source last updated 2014-06-02

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
180 days

What was measured

Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3-5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0.

Analysis population: All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type.

Groups in this outcome

Cohort A & B - Lymphoid & Myeloid Disease

Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 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
Cohort A & B - Lymphoid & Myeloid Disease124

Reported measurements

Grade II-IV GvHD (MRD n=38)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B - Lymphoid & Myeloid Disease16Not reported730Not reported
Grade II-IV GvHD (MUD n=53)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B - Lymphoid & Myeloid Disease26Not reported1439Not reported
Grade II-IV GvHD (HAPLO n=33)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B - Lymphoid & Myeloid Disease46Not reported2465Not reported
Grade III-IV GvHD (MRD n=38)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B - Lymphoid & Myeloid Disease3Not reported0.212Not reported
Grade III-IV GvHD (MUD=53)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B - Lymphoid & Myeloid Disease13Not reported525Not reported
Grade III-IV GvHD (HAPLO n=33)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B - Lymphoid & Myeloid Disease27Not reported1147Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        30
        value
        16
    title
    Grade II-IV GvHD (MRD n=38)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14
        upper Limit
        39
        value
        26
    title
    Grade II-IV GvHD (MUD n=53)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24
        upper Limit
        65
        value
        46
    title
    Grade II-IV GvHD (HAPLO n=33)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        12
        value
        3
    title
    Grade III-IV GvHD (MRD n=38)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        25
        value
        13
    title
    Grade III-IV GvHD (MUD=53)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        47
        value
        27
    title
    Grade III-IV GvHD (HAPLO n=33)
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    units
    Participants
description
Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3-5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0.
dispersion Type
95% Confidence Interval
groups
  1. description
    Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    OG000
    title
    Cohort A & B - Lymphoid & Myeloid Disease
param Type
NUMBER
population Description
All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type.
reporting Status
POSTED
time Frame
180 days
title
Graft Versus Host Disease
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice