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NCT02684162 · OUTCOME

Disease-free Survival

Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant · Source last updated 2025-11-06

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 1 year

What was measured

Number of participants that are disease free and alive 1 year after study enrollment.

Groups in this outcome

Cohort 1: Relapsed Leukemia Post-transplant

Patients with morphological relapse for AML and MDS at least 90 days post-transplant. MDS patients: Re-appearance of dysplastic changes in the bone marrow, with or without increase in bone marrow blast count, which is pathologically consistent with myelodysplastic syndrome. AML patients: Bone marrow blast count \>/= 5%.

Cohort 2: MRD(Minimal Residual Disease) Post-transplant

Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation.

Cohort 3: Maintenance Treatment Post-transplant

Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic 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
Cohort 1: Relapsed Leukemia Post-transplant13
Cohort 2: MRD(Minimal Residual Disease) Post-transplant18
Cohort 3: Maintenance Treatment Post-transplant24

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Relapsed Leukemia Post-transplant5Not reportedNot reportedNot reportedNot reported
Cohort 2: MRD(Minimal Residual Disease) Post-transplant7Not reportedNot reportedNot reportedNot reported
Cohort 3: Maintenance Treatment Post-transplant20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Number of participants that are disease free and alive 1 year after study enrollment.
groups
  1. description
    Patients with morphological relapse for AML and MDS at least 90 days post-transplant. MDS patients: Re-appearance of dysplastic changes in the bone marrow, with or without increase in bone marrow blast count, which is pathologically consistent with myelodysplastic syndrome. AML patients: Bone marrow blast count \>/= 5%.
    id
    OG000
    title
    Cohort 1: Relapsed Leukemia Post-transplant
  2. description
    Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation.
    id
    OG001
    title
    Cohort 2: MRD(Minimal Residual Disease) Post-transplant
  3. description
    Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic stem cell transplantation.
    id
    OG002
    title
    Cohort 3: Maintenance Treatment Post-transplant
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At 1 year
title
Disease-free Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice