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NCT01812252 · OUTCOME

Overall Survival

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant · Source last updated 2024-02-15

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
Up to 18 months

What was measured

The total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT.

Groups in this outcome

Arm A (Decitabine or Azacitidine)

Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies

Arm B (Induction-like Chemotherapy Regimen)

Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Arm A (Decitabine or Azacitidine)25
Arm B (Induction-like Chemotherapy Regimen)25

Reported measurements

Source class 1

Participants alive after 18 months from start of treatment who received HCT.

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Decitabine or Azacitidine)7Not reportedNot reportedNot reportedNot reported
Arm B (Induction-like Chemotherapy Regimen)10Not reportedNot reportedNot reportedNot reported

Participants alive after 18months from start of treatment who did not receive HCT.

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Decitabine or Azacitidine)2Not reportedNot reportedNot reportedNot reported
Arm B (Induction-like Chemotherapy Regimen)1Not reportedNot reportedNot reportedNot reported

Participants deceased after 18 months from start of treatment who received HCT.

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Decitabine or Azacitidine)5Not reportedNot reportedNot reportedNot reported
Arm B (Induction-like Chemotherapy Regimen)3Not reportedNot reportedNot reportedNot reported

Participants deceased after 18 months from start of treatment who did not receive HCT.

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Decitabine or Azacitidine)11Not reportedNot reportedNot reportedNot reported
Arm B (Induction-like Chemotherapy Regimen)11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        10
      title
      Participants alive after 18 months from start of treatment who received HCT.
    2. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      title
      Participants alive after 18months from start of treatment who did not receive HCT.
    3. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      title
      Participants deceased after 18 months from start of treatment who received HCT.
    4. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        11
      title
      Participants deceased after 18 months from start of treatment who did not receive HCT.
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      25
    units
    Participants
description
The total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT.
groups
  1. description
    Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm A (Decitabine or Azacitidine)
  2. description
    Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies
    id
    OG001
    title
    Arm B (Induction-like Chemotherapy Regimen)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 18 months
title
Overall Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice