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NCT00520130 · OUTCOME

Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells

Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System · Source last updated 2019-03-05

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

Measure
MEDIAN
Unit
% of naive (CCR7+CD45RA+) CD4 Cells
Interval / dispersion
Full Range
Time frame
Recipient recovery at 6, 12 and 24 months post transplant

What was measured

The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry.

Analysis population: A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.

Groups in this outcome

A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm

Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy

B - Cyclosporine (AC) Arm

Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.

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

Analysis denominator · Participants

GroupSource count
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm28
B - Cyclosporine (AC) Arm28

Reported measurements

6 mo (TMS=28; AC= 28)
Values in % of naive (CCR7+CD45RA+) CD4 Cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm24Not reported265Not reported
B - Cyclosporine (AC) Arm1Not reported022Not reported
12 mo (TMS=25; AC= 21)
Values in % of naive (CCR7+CD45RA+) CD4 Cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm22Not reported548Not reported
B - Cyclosporine (AC) Arm7Not reported042Not reported
24 mo (TMS=18; AC= 13)
Values in % of naive (CCR7+CD45RA+) CD4 Cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm20Not reported460Not reported
B - Cyclosporine (AC) Arm25Not reported160Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        65
        value
        24
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        22
        value
        1
    title
    6 mo (TMS=28; AC= 28)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        48
        value
        22
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        42
        value
        7
    title
    12 mo (TMS=25; AC= 21)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        60
        value
        20
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        60
        value
        25
    title
    24 mo (TMS=18; AC= 13)
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      28
    units
    Participants
description
The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry.
dispersion Type
Full Range
groups
  1. description
    Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
    id
    OG000
    title
    A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm
  2. description
    Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
    id
    OG001
    title
    B - Cyclosporine (AC) Arm
param Type
MEDIAN
population Description
A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.
reporting Status
POSTED
time Frame
Recipient recovery at 6, 12 and 24 months post transplant
title
Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells
type
PRIMARY
unit Of Measure
% of naive (CCR7+CD45RA+) CD4 Cells

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Preserved source evidence · Not medical advice