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NCT01300572 · OUTCOME

Duration of Remission

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS · Source last updated 2019-12-10

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
1 year

What was measured

Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease. Relapse Criteria: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood 2. After partial remission (PR): increase of blasts cells in the marrow to \>50% of those during PR 3. Extramedullary disease confirmed cytologically or histologically.

Analysis population: Study participants who relapsed after achieving complete remission after transplant.

Groups in this outcome

Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)

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

Analysis denominator · Participants

GroupSource count
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)13

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)213Not reported69351Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69
        upper Limit
        351
        value
        213
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease. Relapse Criteria: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood 2. After partial remission (PR): increase of blasts cells in the marrow to \>50% of those during PR 3. Extramedullary disease confirmed cytologically or histologically.
dispersion Type
Full Range
groups
  1. description
    PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)
    id
    OG000
    title
    Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
param Type
MEDIAN
population Description
Study participants who relapsed after achieving complete remission after transplant.
reporting Status
POSTED
time Frame
1 year
title
Duration of Remission
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice