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NCT00040846 · OUTCOME

Evaluate the Risk for Disease Progression and Relapse

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies · Source last updated 2020-01-29

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
1 year after transplant

What was measured

Percentage patients who relapsed/progressed within 1 year post-transplant.

Analysis population: No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Groups in this outcome

Dose Level 1 (No Campath)

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO

Dose Level 2 (0.025 mg/kg/Day Campath)

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV

Dose Level 3 (0.050 mg/kg/Day Campath)

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV

Dose Level 4 (0.10 mg/kg/Day Campath)

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV

Dose Level 5 (0.20 mg/kg/Day Campath)

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV

Dose Level 6 (0.40 mg/kg/Day Campath)

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: 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
Dose Level 1 (No Campath)60
Dose Level 2 (0.025 mg/kg/Day Campath)0
Dose Level 3 (0.050 mg/kg/Day Campath)0
Dose Level 4 (0.10 mg/kg/Day Campath)0
Dose Level 5 (0.20 mg/kg/Day Campath)0
Dose Level 6 (0.40 mg/kg/Day Campath)0

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 (No Campath)21.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21.7
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
Percentage patients who relapsed/progressed within 1 year post-transplant.
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
    id
    OG000
    title
    Dose Level 1 (No Campath)
  2. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    OG001
    title
    Dose Level 2 (0.025 mg/kg/Day Campath)
  3. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    OG002
    title
    Dose Level 3 (0.050 mg/kg/Day Campath)
  4. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    OG003
    title
    Dose Level 4 (0.10 mg/kg/Day Campath)
  5. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    OG004
    title
    Dose Level 5 (0.20 mg/kg/Day Campath)
  6. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    OG005
    title
    Dose Level 6 (0.40 mg/kg/Day Campath)
param Type
NUMBER
population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
reporting Status
POSTED
time Frame
1 year after transplant
title
Evaluate the Risk for Disease Progression and Relapse
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice