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NCT00096161 · OUTCOME

Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism

Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant · Source last updated 2020-01-31

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
Not reported
Time frame
From the time of enrollment maintained to day 56 after the last DLI, up to Day 112

What was measured

A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.

Analysis population: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.

Groups in this outcome

Group 1A (Pentostatin, DLI Dose Level 1)

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

Group 1B (Pentostatin, DLI Dose Level 2)

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV

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

Analysis denominator · Participants

GroupSource count
Group 1A (Pentostatin, DLI Dose Level 1)20
Group 1B (Pentostatin, DLI Dose Level 2)10
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)6
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)0

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1A (Pentostatin, DLI Dose Level 1)60Not reportedNot reportedNot reportedNot reported
Group 1B (Pentostatin, DLI Dose Level 2)30Not reportedNot reportedNot reportedNot reported
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)33.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      0
    units
    Participants
description
A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.
groups
  1. description
    Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
    id
    OG000
    title
    Group 1A (Pentostatin, DLI Dose Level 1)
  2. description
    Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
    id
    OG001
    title
    Group 1B (Pentostatin, DLI Dose Level 2)
  3. description
    Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
    id
    OG002
    title
    Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
  4. description
    Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV
    id
    OG003
    title
    Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
param Type
NUMBER
population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
reporting Status
POSTED
time Frame
From the time of enrollment maintained to day 56 after the last DLI, up to Day 112
title
Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice