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NCT03272633 · OUTCOME

Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response

Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies · Source last updated 2023-06-26

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 8 weeks after last protocol treatment

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Analysis population: no data was collected. Refers to the Cohort 1 Arm

Groups in this outcome

Cohort I (Initial IHC Within 42 Days)

Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies

Cohort II (Initial IHC Within 70 Days or After Relapse)

Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative 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
Cohort I (Initial IHC Within 42 Days)0
Cohort II (Initial IHC Within 70 Days or After Relapse)2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort II (Initial IHC Within 70 Days or After Relapse)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
groups
  1. description
    Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
    id
    OG000
    title
    Cohort I (Initial IHC Within 42 Days)
  2. description
    Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
    id
    OG001
    title
    Cohort II (Initial IHC Within 70 Days or After Relapse)
param Type
COUNT_OF_PARTICIPANTS
population Description
no data was collected. Refers to the Cohort 1 Arm
reporting Status
POSTED
time Frame
Up to 8 weeks after last protocol treatment
title
Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice