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NCT00096161 · OUTCOME

Incidence of Grade IV Acute GVHD

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
Within 100 days after the last DLI

What was measured

Clinical Stage of acute GVHD according to Organ System Skin: 1. \- Maculopapular rash \<25% of body surface 2. \- Maculopapular rash 25-50% of body surface 3. \- Maculopapular rash \>50% body surface area or generalized erythroderma 4. \- Generalized erythroderma with bullous formation and desquamation Liver: 1. \- Bilirubin 2-3 mg/dl 2. \- Bilirubin 3.1-6 mg/dl 3. \- Bilirubin 6.1-15 mg/dl 4. \- Bilirubin \>15 mg/dl Gut: 1. \- \>500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD 2. \- \>1000 -1500 mL diarrhea per day 3. \- \>1500 mL diarrhea per day 4. \- \>1500 mL diarrhea per day plus severe abdominal pain with or without ileus Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI

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)5Not reportedNot reportedNot reportedNot reported
Group 1B (Pentostatin, DLI Dose Level 2)0Not reportedNot reportedNot reportedNot reported
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
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
Clinical Stage of acute GVHD according to Organ System Skin: 1. \- Maculopapular rash \<25% of body surface 2. \- Maculopapular rash 25-50% of body surface 3. \- Maculopapular rash \>50% body surface area or generalized erythroderma 4. \- Generalized erythroderma with bullous formation and desquamation Liver: 1. \- Bilirubin 2-3 mg/dl 2. \- Bilirubin 3.1-6 mg/dl 3. \- Bilirubin 6.1-15 mg/dl 4. \- Bilirubin \>15 mg/dl Gut: 1. \- \>500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD 2. \- \>1000 -1500 mL diarrhea per day 3. \- \>1500 mL diarrhea per day 4. \- \>1500 mL diarrhea per day plus severe abdominal pain with or without ileus Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI
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
Within 100 days after the last DLI
title
Incidence of Grade IV Acute GVHD
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice