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NCT00597714 · OUTCOME

Disease Free Survival

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant · Source last updated 2014-06-02

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
95% Confidence Interval
Time frame
2 years

What was measured

Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.

Analysis population: All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).

Groups in this outcome

Cohort A & B- Lymphoid & Myeloid Disease

Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.

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

Analysis denominator · Participants

GroupSource count
Cohort A & B- Lymphoid & Myeloid Disease124

Reported measurements

Matched Related Donors (MRD); n=38
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B- Lymphoid & Myeloid Disease47Not reported2963Not reported
Matched Unrelated Donors (MUD); n=53
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B- Lymphoid & Myeloid Disease23Not reported1236Not reported
Haploidentical related (HAPLO) donors; n=33
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A & B- Lymphoid & Myeloid Disease16Not reported533Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29
        upper Limit
        63
        value
        47
    title
    Matched Related Donors (MRD); n=38
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12
        upper Limit
        36
        value
        23
    title
    Matched Unrelated Donors (MUD); n=53
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        33
        value
        16
    title
    Haploidentical related (HAPLO) donors; n=33
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    units
    Participants
description
Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.
dispersion Type
95% Confidence Interval
groups
  1. description
    Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    OG000
    title
    Cohort A & B- Lymphoid & Myeloid Disease
param Type
NUMBER
population Description
All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).
reporting Status
POSTED
time Frame
2 years
title
Disease Free Survival
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice