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NCT00118352 · OUTCOME

Disease Progression/Relapse

Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2017-05-30

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
Up to 5 years

What was measured

CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.

Groups in this outcome

Dose Level 1 (No Campath)

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Dose Level 2 (40mg Total Dose Campath)

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Dose Level 3 (60mg Total Dose Campath)

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

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

Analysis denominator · Participants

GroupSource count
Dose Level 1 (No Campath)12
Dose Level 2 (40mg Total Dose Campath)0
Dose Level 3 (60mg Total Dose Campath)0

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 (No Campath)25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
groups
  1. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
    id
    OG000
    title
    Dose Level 1 (No Campath)
  2. description
    Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
    id
    OG001
    title
    Dose Level 2 (40mg Total Dose Campath)
  3. description
    Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
    id
    OG002
    title
    Dose Level 3 (60mg Total Dose Campath)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 5 years
title
Disease Progression/Relapse
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice