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NCT03128359 · OUTCOME

Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) 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 survival probability
Interval / dispersion
95% Confidence Interval
Time frame
From stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.

What was measured

Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be 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 survival probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)53Not reported2972Not reported
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)84Not reported5995Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29
        upper Limit
        72
        value
        53
      2. group Id
        OG001
        lower Limit
        59
        upper Limit
        95
        value
        84
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be 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 stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.
title
Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year
type
PRIMARY
unit Of Measure
percentage of survival probability

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Preserved source evidence · Not medical advice