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NCT03128359 · OUTCOME

Overall Survival (OS) at 1 Year

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant · Source last updated 2024-01-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of probability
Interval / dispersion
95% Confidence Interval
Time frame
From start of transplant to death, or last follow up, whichever occurs first, assessed for up to 1 year.

What was measured

Estimates was calculated using the Kaplan-Meier method, Greenwood formula was used to calculate SE, and log-log transformation method was used to construct 95% confidence intervals. Each patient's vital status was monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event was censored at his/her date of last contact.

Groups in this outcome

Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)

Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV

Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)

Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI

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

Analysis denominator · Participants

GroupSource count
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)19
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)19

Reported measurements

Source class 1
Values in percentage of probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)68Not reported4284Not reported
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)100Not reportedNANAThe 95% confidence intervals were not calculable because no participant reached the event at the final time point for assessment.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42
        upper Limit
        84
        value
        68
      2. comment
        The 95% confidence intervals were not calculable because no participant reached the event at the final time point for assessment.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Estimates was calculated using the Kaplan-Meier method, Greenwood formula was used to calculate SE, and log-log transformation method was used to construct 95% confidence intervals. Each patient's vital status was monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event was censored at his/her date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
    id
    OG000
    title
    Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
  2. description
    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI
    id
    OG001
    title
    Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
param Type
NUMBER
reporting Status
POSTED
time Frame
From start of transplant to death, or last follow up, whichever occurs first, assessed for up to 1 year.
title
Overall Survival (OS) at 1 Year
type
SECONDARY
unit Of Measure
percentage of probability

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Preserved source evidence · Not medical advice