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NCT00423514 · OUTCOME

Response to Therapy

Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease · Source last updated 2022-12-27

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
1 year

What was measured

* A complete response (CR) will be defined as less than 5% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A complete response except platelets (CRp) will be defined as less than 5% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A partial response (PR) will be defined as 5%-25% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A partial response except platelets (PRp) will be defined as 5%-25% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul

Groups in this outcome

Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL

This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).

Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL

This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).

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

Analysis denominator · Participants

GroupSource count
Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL31
Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL7

Reported measurements

Source class 1

Relapse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL1Not reportedNot reportedNot reportedNot reported
Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL0Not reportedNot reportedNot reportedNot reported

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL27Not reportedNot reportedNot reportedNot reported
Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL4Not reportedNot reportedNot reportedNot reported

Not evaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL3Not reportedNot reportedNot reportedNot reported
Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Relapse
    2. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        4
      title
      Complete Response
    3. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      title
      Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      7
    units
    Participants
description
* A complete response (CR) will be defined as less than 5% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A complete response except platelets (CRp) will be defined as less than 5% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A partial response (PR) will be defined as 5%-25% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A partial response except platelets (PRp) will be defined as 5%-25% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul
groups
  1. description
    This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).
    id
    OG000
    title
    Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL
  2. description
    This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).
    id
    OG001
    title
    Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
1 year
title
Response to Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice